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Clinical Trials

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Acute Coronary Syndrome

(6/1/1999 - 12/1/2002) Phase III. Evaluating the long term safety and efficacy of an Investigational Product combination in high risk patients after a heart attack / Myocardial Infarction. Males and Females with previous heart attack / Myocardial Infarction.

Recent Heart Attack

(7/1/2010 - ongoing) Currently recruiting participants for a study related to Acute Coronary Syndrome or recent heart attack with a Type II Diabetes diagnosis. Males and Females, 30 years of age and older, who have experienced a “cardiac event” within the past 12 weeks.

Recent Heart Attack

(7/1/2008 - ongoing) Phase III. Evaluating the effect of an Investigational Product on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS). Males and Females, 45 years of age and older, who have experienced a “cardiac event” within the past 8 weeks.

Allergies

(5/1/2008 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product in subjects with grass pollen rhinoconjunctivitis. Males and Females, 18 to 50 years of age, with grass pollen allergies.

Anemia

(5/1/2005 - 4/1/2009) Phase III. A trial to reduce cardiovascular events with Investigational Product therapy. Males and Females with Type II Diabetes and Anemia related to Chronic Kidney Disease.

(12/1/2006 - 8/1/2008) Phase III. Aplastic Anemia and MDS observational study. Males and Females, 10 years of age and older, with a diagnosis of Aplastic Anemia or MDS.

Ankle Sprain

(8/1/2010 - ongoing) Currently recruiting participants who have a experienced an ankle sprain within the past 2 days for a pain patch study. Males and Females, 14 years of age and older, with a recent ankle sprain.

(5/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as a patch therapy in patients with recent ankle sprain. Males and Females, 18 years of age and older, who have experienced an ankle sprain within the past 48 hours.

(2/1/2009 - 6/1/2009) Phase III. Evaluating the efficacy and safety of patch therapy for the topical treatment of mild to moderate Ankle Sprain. Males and Females, 17 to 75 years of age, have experienced an ankle sprain within 60 hours.

Asthma

(9/1/2006 - 5/1/2007) Phase III. Studying the effects of an Investigational nasal spray on common cold symptoms and asthma exacerbations when exposed to someone with a cold. Males and Females, 6 to 65 years of age, a diagnosis of asthma and taking asthma medication.

(10/1/2009 - ongoing) Phase III. Evaluating the effect of an Investigational Product in atopic asthmatics with good lung capacity. Males and Females, 12 to 75 years of age, with allergy induced asthma.

Atrial Fibrillation

(8/1/2005 - 1/1/2008) Phase III. Evaluating the efficacy of Investigational Product for the prevention of hospitalization or death in patients with Atrial Fibrillation/Atrial Flutter. Males and Females, 70 years of age and older (with cardiovascular risk factors) or 75 years of age (with or without risk factors), with Atrial Fibrillation or Atrial Flutter.

(9/1/2007 - 10/1/2008) Phase III. Evaluating the efficacy and safety of an Investigational nasal spray versus placebo in addition to antibiotics in relieving symptoms of Sinusitis. Males and Females, 12 years of age and older, with symptoms of Sinusitis.

(7/1/2008 - ongoing) Phase III. Evaluating efficacy and safety of Investigational Product in preventing cardiac events in subjects with Atrial Fibrillation. Males and Females, 18 years of age and older, with Atrial Fibrillation or Flutter and cardiac risk factors.

(10/1/2007 - 6/1/2008) Phase III. Evaluating the superiority of Investigational Product when given to subjects with active Rheumatoid Arthritis (RA). Males and Females, 18 years of age and older, with active Rheumatoid Arthritis.

(5/1/2008 - 8/1/2010) Phase III. Evaluating efficacy and safety of Investigaional Product versus warfarin in preventing cardiac events in patients with Atrial Fibrillation. Males and Females diagnosed with Atrial Fibrillation.

Study 1

(7/1/2010 - ongoing) Currently recruiting participants for a registry trial related to Atrial Fibrillation. The study will follow patients with Atrial Fibrillation, however, it does not involve investigational medication. Males and Females, 18 years of age and older, with Atrial Fibrillation.

Study 2

(12/1/2008 - ongoing) Currently recruiting participants for a study related to Atrial Fibrillation. Males or Females, 21 years of age and older, with a history of Atrial Fibrillation, an irregular or racing heart.

Constipation

(2/9/2009 - 8/31/2010) Phase III. An open label study to evaluate the safety of Investigational Product in treating Opioid Induced Constipation. Males and Females, 18 years of age and older with a history of constipation and pain on opioid therapy.

COPD

(4/1/2009 - ongoing) Phase III. A 12 week study to evaulate the safety and effectiveness of an Investigational Product when used for once daily treatment of COPD and in combination with Spiriva or placebo. Males and Females, 40 years of age and older, with a diagnosis of COPD or Chronic Obstructive Pulmonary Disease.

(7/1/2009 - ongoing) Phase III. Evaluating the safety, efficacy and tolerability of Investigational Product in patients with moderate to severe COPD. Males and Females, 40 years of age and older, who have been diagnosed with COPD or Chronic Obstructive Pulmonary Disease.

Deep Vein Thrombosis

(5/1/2008 - 2/1/2009) Phase III. Evaluating the use of Investigational Product for the treatment of Deep Vein Thrombosis and Pulmonary Embolism. Males and Females, 18 years of age and older, with Deep Vein Thrombosis and Pulmonary Embolism.

Diabetes (Type II)

(7/1/2008 - ongoing) Phase III. Evaluating the efficacy of an Investigational Product when used in combination with Metformin, ACTOS or Avandia. Males and Females, 18 years of age and older, with Type II Diabetes taking Metformin, ACTOS or Avandia.

(10/1/2005 - 12/1/2005) Phase III. Evaluating the efficacy and safety of different titrations of Investigational Product in patients with Type II Diabetes. Males and Females, 18 years of age and older, with Type II Diabetes.

(6/1/2006 - 12/1/2006) Phase III. Evaluating the efficacy, safety and tolerability of three dose levels of Investigational Product in subjects with Type II Diabetes. Males and Females with a diagnosis of Type II Diabetes.

(8/1/2006 - 9/1/2007) Phase III. Comparing the efficacy of an Investigational Product versus TZD as add-on therapy in patients with Type II Diabetes currently on Metformin therapy. Males and Females, 18 to 80 years of age, with Type II Diabetes.

(2/1/2007 - 4/1/2008) Phase II. Evaluating weekly treatment of an Investigational Product in subjects with Type II Diabetes. Males and Females, 18 to 80 years of age, with Type II Diabetes and currently on Metformin therapy.

(5/1/2004 - 12/1/2009) Phase III. Evaluating the reduction in occurrence of diabetic macular edema. Males and Females with diabetic macular edema.

(1/1/2002 - 9/1/2009) Phase III. Evaluating the efficacy and safety of long term administration of a combination of Investigational Products in the prevention of Diabetes and Cardiovascular Outcome in patients with impaired glucose tolerance. Males and Females with Impaired Glucose Tolerance (IGT).

(6/1/2007 - 8/1/2007) Phase III. Evaluating the efficacy and safety of Investigational Product in combination with ACTOS in subjects with Type II Diabetes. Males and Females, 18 to 80 years of age, with Type II Diabetes.

(10/25/2008 - ongoing) Phase III. A study to evaluate the efficacy and safety of Investigational Product with Metformin in patients with Type II Diabetes. Males and Females, 18 to 78 years of age, with Type II Diabetes that are taking Metformin and looking for additional therapy.

(12/1/2009 - 8/31/2010) Phase II. A multi-center, double-blind, placebo-controlled, randomized study to compare the effect of a subcutaneous IP administration to placebo in patients with Impaired Glucose Tolerance or patients with Type 2 Diabetes treated with differing baseline diabetes therapies. Males and Females, 18 to 74 years of age with Impaired Glucose Tolerance or Type II Diabetes.

(12/1/2008 - ongoing) Phase III. Evaluating the efficacy and safety of Investigational Product as monotherapy in patients with Type II Diabetes. Males and Females, 18 years of age and older, with Type II Diabetes that are not taking diabetic medication.

Study 1

(8/1/2010 - ongoing) *Study start anticipated for August 2010* Currently recruiting participants for a study related to Type II Diabetes. Males and Females, 18 years of age or older, with Type II Diabetes. Participants CAN be taking insulin to control their Diabetes for this trial.

Study 2

(2/1/2009 - ongoing) Currently recruiting participants for a study related to Type II Diabetes. Males and Females, 18 to 80 years of age, with Type II Diabetes and inadequately controlled with Metformin.

Study 3

(2/1/2010 - ongoing) Currently recruiting participants for a trial related to Type II Diabetes and Cardiovascular Risk. Males 45 years of age and older, Females 50 years of age and older with a diagnosis of Type II Diabetes and a history of Cardiovascular Disease.

Study 4

(1/1/2010 - ongoing) Currently recruiting participants for a study related to Type II Diabetes. Males and Females, 18 years of age and older who are at risk for developing Type II Diabetes or are considered "pre-diabetic."

Study 5

(12/1/2009 - ongoing) Currently recruiting participants for a study related to Type II Diabetes. Males and Females, 18 to 80 years of age with Type 2 Diabetes that is inadequately controlled with diet and exercise alone.

Study 6

(6/1/2010 - ongoing) Currently recruiting participants with Type II Diabetes and Cardiovascular Disease for a study related to Type II Diabetes. Males and Females, 50 years of age and older, with Type II Diabetes and Cardiovascular Disease (previous stroke, heart attack, coronary artery disease).

Erectile Dysfunction

(8/1/2010 - ongoing) *Study start anticipated for early August 2010* Currently recruiting male participants for a study related to Erectile Dysfunction. Male participants, 18 years of age or older, with a monogamous partner and have experienced ED for a period of at least 3 months.

Fibromyalgia

(7/1/2008 - 8/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product versus placebo in patients diagnosed with Fibromyalgia as assessed by the American College of Rheumatology (ACR). Males and Females, 18 years of age and older, with diagnosis of Fibromyalgia.

Gout

(4/1/2010 - ongoing) Currently recruiting participants for a study related to Gout. Males and Females, 50 years of age and older, with a history of Gout and Cardiovascular Disease.

High Blood Pressure

(5/1/2006 - 7/1/2007) Phase III. Evaluating the efficacy and safety of a triple therapy combination drug in comparison to 3 sets of double therapy combinations in patients with moderate to severe hypertension. Males and Females, 18 to 86 years of age, with Hypertension.

(11/1/2006 - 3/1/2008) Phase III. Evaluating the efficacy and safety of different doses of 2 separate Hypertensive medications or a combination of those medications. Males and Females, 18 years of age and older with Stage II Hypertension.

(2/1/2008 - 3/1/2008) Phase III. Evaluating the incidence of hypotension in elderly hypertensive patients following administration of a combination of COREG CR and lisinopril. Males and Females, 65 years of age and older, with Hypertension.

(6/1/1999 - 1/1/2005) Phase III. Evaluating the effect of an Investigational Product in preventing Hypertension. Males and Females with Stage II Hypertension.

(10/1/2002 - 11/1/2002) Phase III. Evaluating the efficacy of dosing two Investigational Products compared to uptitration of one Investigational Product in patients with Hypertension. Males and Females with Stage II Hypertension.

(1/1/2003 - 3/1/2004) Phase III. Evaluating the efficacy and safety of two Investigational Products combined and alone in patients with Hypertension. Males and Females with Stage II Hypertension.

(4/9/2009 - ongoing) Currently recruiting participants for a study related to Type II Diabetes and High Blood Pressure. Males and Females, 18 years of age and older with both Type II Diabetes and High Blood Pressure.

(12/1/2008 - 2/10/2010) Phase III. Evaluating efficacy and safety of Investigational Product in comparison to Amlodipine (Norvasc) in patients with Hypertension and Diabetes. Males and Females, 18 years of age and older with Hypertension and Type II Diabetes.

(7/1/2009 - 3/1/2010) Phase IV. A trial to compare 12 weeks of Investigational Product to Placebo when added to a stable regimen of Lisinopril or Losartan in patients with Hypertension. Males and Females, 18 to 85 years of age with Hypertension.

(4/1/2008 - 10/1/2008) Phase III. Comparison trial of subjects with Hypertension who achieve target blood pressure while receiving either COREG CR + lisinopril or lisinopril monotherapy. Males and Females, 18 to 80 years of age and older, with Stage 1 or 2 Essential Hypertension.

(4/1/2008 - 9/1/2009) Phase III. Evaluating efficacy and tolerability of Investigational Product in comparison with Carvedilol (Coreg) in patients with Coronary Artery Disease and Hypertension. Males and Females, 18 to 85 years of age, with a history of Coronary Artery Disease and Hypertension.

(10/1/2008 - 4/1/2009) Phase III. Evaluating the efficacy and safety of Investigational Product in comparison to HCTZ in subjects with stage 2 systolic Hypertension. Males and Females, 55 years of age and older, with Hypertension.

High Cholesterol

(4/1/2000 - 8/1/2000) Phase III. Evaluating the effects of an Investigational Product on bone density and cholesterol. Males and Females with low bone density and high cholesterol.

Hot Flashes

Post-Menopausal Symptoms

(2/9/2009 - ongoing) Phase III. A efficacy and safety study to evaluate hte effect of Investigational Product on Endometrial Hyperplasia and Osteoporosis prevention. Postmenopausal Females, 40 to 65 years of age, with menopausal symptoms.

Influenza

(12/1/2008 - ongoing) Currently recruiting participants for a study related to Influenza. Males or Females, 1 year of age and older, with symptoms of influenza (fever, cough, runny nose).

Irritable Bowel Syndrome

Study 1

(4/1/2010 - ongoing) Currently recruiting participats for a study related to Irritable Bowel Syndrome. Males and Females, 18 to 65 years of age, with diarrhea predominant IBS who have had a colonoscopy within the last 5 years.

Study 2

(3/1/2010 - ongoing) Currently recruiting participants for a study related to IBS. Males or Females, 18 to 79 years of age, with recurrent symptoms of IBS and diarrhea.

Low Sexual Desire

Study 1

(7/1/2008 - ongoing) Currently recruiting female participants for a study related to loss of sexual desire (females). Females, 50 years of age and older, either postmenopausal OR have had a hysterectomy, and are experiencing a lack of sexual desire.

Study 2

(7/1/2008 - ongoing) Currently recruiting females for a study related to low sexual desire. Females, 30 to 65 years of age, have had a hysterectomy within the last 15 years, are taking a hormone replacement therapy, and are experiencing a lack of sexual desire.

Study 3

(12/1/2009 - ongoing) Currently recruiting females for a study related to low sexual desire. Females that are postmenopausal and are experiencing a lack of sexual desire.

Study 4 (Extension to Study 3)

(2/1/2010 - ongoing) 28 week open label extension trial for females with a primary diagnosis of HSDD (Hypoactive Sexual Desire Disorder) who have successfully completed Low Sexual Desire Study 3.

Low Sodium

(7/1/2008 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product versus placebo in patients with Hyponatremia (low sodium) due to SIADH. Males and Females, 18 years of age and older, with chronic Hyponatremia (low sodium).

(7/1/2007 - 12/1/2008) Phase IIIb. Studying the effects of titrated Investigational Product on function of hyponatremic patients. Males and Females, 50 years of age and older, with Hyponatremia (Low Sodium).

(8/1/2009 - 8/1/2010) Phase III. A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Investigational Product in Subjects with Euvolemic Hyponatremia. Males and Females, 18 years of age and older, with low sodium levels.

(2/1/2010 - ongoing) Phase III. International, Multicenter, Study of a Twenty-Eight Week, Open-Label, Titrated Oral Investigational Product in Patients with Chronic Hyponatremia: Extension to Core Study. Males and Females, 18 years of age and older, with low sodium levels and have completed the core low sodium trial (described above).

Obesity

(1/1/2011 - ongoing) *NOTE: This study has delayed Study Start up until early 2011* Currently recruiting participants for an upcoming study related to Obesity and high cholesterol. Males and Females, 18 to 75 years of age with mild, moderate or severe obesity (BMI 30-42) and with mixed dyslipidemia.

Osteoarthritis

(2/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy of Investigational Product in subjects with Osteoarthritis of the Knee. Males and Females, 40 years of age and older, with Osteoarthritis of the Knee.

(9/1/2010 - ongoing) *Study start scheduled for early September 2010* Currently recruiting participants for a study related to Osteoarthritis of the Knee. Males and Females, 18 to 75 years of age, with Osteoarthritis of the Knee

(6/1/2008 - 5/1/2009) Phase II. A 1-year extension study to evaluate the safety, tolerability and effectiveness of Investigational Product in subjects with Osteoarthritis of the Knee. Males and Females, who have successfully completed the Core trial, with Osteoarthritis of the Knee.

(2/9/2009 - 8/31/2010) Phase III. Evaluating the efficacy and safety of Investigational Product alone or in combination with NSAIDs versus NSAIDs alone in patients with Osteoarthritis of the Knee or Hip. Males and Females, 18 years of age and older, with Osteoarthritis of the Knee and Hip.

(9/1/2007 - ongoing) Phase III. Evaluating safety and efficacy of Investigational Product in subjects with Osteoarthritis of the Knee. Males and Females, 40 years of age and older, with Osteoarthritis of the Knee.

Osteopenia

(10/1/2004 - 10/1/2007) Phase III. Evaluating the efficacy and safety of IV Investigational Product administered either once or twice in a two year time period in the prevention of bone loss. Postmenopausal Females, 45 years of age and older, with Osteopenia.

Osteoporosis

(5/1/2004 - 11/1/2009) Phase III. Evaluating the effects of Investigational Product on vertebral fracture and breast cancer incidence in postmenopausal women with Osteoporosis or low bone density. Postmenopausal Females, 60 to 85 years of age, with Osteoporosis or low bone density.

(2/1/2004 - 8/1/2005) Phase III. Evaluating the effects of calcium supplementation on the efficacy and safety of Investigational Product in postmenopausal women with Osteoporosis. Postmenopausal Females with Osteoporosis.

(2/1/2005 - 4/1/2008) Phase IV. Open label extension trial evaluating two IV Investigational Product regimens in women with postmenopausal Osteoporosis who have completed the Core Osteoporosis trial. Postmenopausal Females with Osteoporosis who have successfully completed the Core Osteoporosis trial.

(12/1/2004 - 1/1/2006) Phase III. An open label study to investigate patient satisfaction with a transition from once-weekly Osteoporosis therapy to once-monthly dosed Osteoporosis therapy. Postmenopausal Females with Osteoporosis or Osteopenia on current therapy for their diagnosis.

(6/1/2003 - 6/1/2005) Phase III. An open label extension trial of the safety and efficacy of Investigational Product in women with postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis who participated and successfully completed the Core trial.

(10/1/2000 - 9/1/2003) Phase III. Evaluating the effect of Investigational Product on fracture incidence in postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis.

(1/1/1996 - 1/1/2000) Phase III. Evaluating the efficacy of an Investigational Product in the treatment of Osteoporosis in postmenopausal women. Postmenopausal Females with Osteoporosis.

(1/1/2003 - 2/1/2005) Phase III. Evaluating the efficacy and safety of two Investigational Product dose regimens versus oral Investigational Product in postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis.

(1/1/2002 - 4/1/2007) Phase III. Evaluating the efficacy and safety of Investigational Product in the treatment of Osteoporosis in postemenopausal women taking calcium plus Vitamin D. Postmenopausal Females with Osteoporosis.

(9/1/2007 - 8/1/2010) Phase III. Open-label study to evaluate the adherence, preference and satisfaction of Investigational Product and Alendronate (Fosomax) in postmenopausal women with low bone mineral density. Postmenopausal Females, 55 years of age and older, with Osteoporosis or low bone mineral density.

(5/1/2007 - 12/1/2009) Phase III. Evaluating the effect on renal function of alendronate in different administrations in postmenopausal women with Osteoporosis or low bone mineral density. Postmenopausal Females, 65 years of age and older, with Osteopororis or low bone mineral density.

(10/1/2008 - ongoing) Phase III. An Extension Osteoporosis trial to evaluate the efficacy and long term safety of Investigational Product in postmenopausal women with Osteoporosis. Females with Osteoporosis who have completed the Core and Extension 1 Osteoporosis trial.

(7/1/2006 - 4/1/2008) Phase III. Evaluating the safety and efficacy of transitioning therapy from Alendronate to Investigational Product in postmenopausal women with low bone mineral density. Postmenopausal Females, 55 years of age and older, with Osteoporosis or low bone mineral density.

(5/1/2005 - 8/1/2006) Phase III. Comparing the efficacy and safety of once monthly oral Investigational Product versus once weekly oral Investigational Product in postmenopausal women with Osteoporosis. Postmenopausal Females, 55 to 84 years of age, and are naive to Osteoporosis medication.

(5/1/2005 - 7/1/2009) Phase III. A 3 year extension trial to evaluate the long term safety and efficacy of Investigational Product in the treatment of Osteoporosis in postmenopausal women taking calcium and vitamin D. Postmenopausal Females with Osteoporosis who have successfully completed the Core Osteoporosis trial.

(3/1/2006 - 12/1/2008) Phase IV. An observational study to determine the pattern of care and outcomes associated with bone loss in postmenopausal women. Postmenopausal Females, 18 years of age and older, currently taking Calcium or Osteoporosis medication to prevent bone loss.

Study 1

(7/22/2009 - ongoing) Phase III. Post menopausal females, 55 years of age and older, with Osteoporosis.

Study 2

(4/1/2010 - ongoing) *Study is currently on hold* Currently recruiting participants for a study related to Osteoporosis. Males and Females, 65 to 85 years of age, with decreased bone mineral density (BMD) who are at risk for hip fracture.

Other

Vaccine

(4/1/2008 - 4/16/2010) Phase III. Evaluating safety, tolerability and immunogenicity of an Investigational Vaccine compared with an FDA-approved vaccine. Males and Females, 70 years of age and older, with previous dose of FDA-approved vaccine.

Overactive Bladder

(10/1/2007 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as an "add-on" therapy in men with symptoms of Overactive Bladder. Males, 40 years of age and older, with symptoms of Overactive Bladder on alpha blocker therapy.

Pink Eye

(5/1/2006 - 5/1/2007) Phase III. A study to evaluate the effect of an Investigational Eye Drop in comparison to Vigomox in treating Pink Eye (Bacterial Conjunctivitis). Males and Females, 1 year of age and older, with active Pink Eye (Bacterial Conjunctivitis).

Rheumatoid Arthritis

(5/1/2004 - 3/1/2005) Phase III. Evaluating the effect of Investigational Product versus placebo on daytime function in subjects with insomnia related to Rheumatoid Arthritis. Males and Females with Insomnia related to Rheumatoid Arthritis.

Shoulder Strain

(7/1/2010 - ongoing) Currently recruiting participants who have a experienced a shoulder strain within the past 5 to 15 days for a pain patch study. Males and Females, 14 years of age and older, with a recent shoulder strain.

Sinusitis

(8/1/2000 - 11/1/2000) Phase III. Evaluating the effect of a tablet Investigational Product in treating viral upper respiratory illness in adults. Adult Males and Females with Viral Upper Respiratory Illness.

Tendonitis/Bursitis

(12/1/2006 - 5/1/2007) Phase III. Efficacy, tolerability and safety of a topical patch in treating pain from Tendonitis or Bursitis of the shoulder, elbow or knee. Males and Females, 18 years of age and older, with a diagnosis within 15 days of Tendonitis or Bursitis of the shoulder, elbow or knee.

(5/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as a patch therapy in patients with recent shoulder pain. Males and Females, 18 years of age and older, who have experienced acute shoulder pain within the past 48 hours.

Wrist Sprain/Strain

(2/1/2009 - 7/1/2009) Phase III. Evaluating the efficacy and safety of patch therapy for the topical treatment of pain due to mild to moderate wrist sprain, strain or contusion. Males and Females with a wrist sprain, strain or contusion within the past 60 hours.

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