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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. PRA International |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00637728 |
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer
Condition | Intervention | Phase |
---|---|---|
Anorexia Cachexia Weight Loss |
Drug: Megestrol acetate concentrated suspension 110 mg/mL Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-Associated Anorexia in Subjects With Lung or Pancreatic Cancer |
Enrollment: | 5 |
Study Start Date: | June 2006 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Megestrol acetate concentrated suspension 110 mg/mL
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Drug: Megestrol acetate concentrated suspension 110 mg/mL
Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
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2: Placebo Comparator
Placebo suspension
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Drug: Placebo
Placebo oral suspension, 5 mL once daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Innovative Medical Research of South Florida, Inc | |
Miami, Florida, United States, 33179 | |
United States, Maryland | |
Western Maryland Health System | |
Cumberland, Maryland, United States, 21502 | |
United States, South Carolina | |
Lowcountry Hematology & Oncology, PA | |
Mt. Pleasant, South Carolina, United States, 29464 |
Study Chair: | Lynn D Kramer, MD | Par Pharmaceutical, Inc. |
Principal Investigator: | John N Mehanna, MD | Western Maryland Health System |
Principal Investigator: | M.Daud Nawabi, MD | Lowcountry Hematology & Oncology, PA |
Principal Investigator: | Marc A Saltzman, MD | Innovative Medical Research of South Florida, Inc |
Responsible Party: | Par Pharmaceutical, Inc ( VP Clinical & Medical Affairs ) |
Study ID Numbers: | 100.2.C.006 |
Study First Received: | March 11, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00637728 |
Health Authority: | United States: Food and Drug Administration |
Megestrol acetate Anorexia Cachexia Lung cancer Pancreatic cancer |
Unintended weight loss Body weight Appetite Megace ES |
Digestive System Neoplasms Signs and Symptoms, Digestive Pancreatic Neoplasms Endocrine System Diseases Cachexia Emaciation Megestrol Body Weight Signs and Symptoms Digestive System Diseases |
Lung Neoplasms Weight Loss Anorexia Body Weight Changes Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Megestrol Acetate Endocrine Gland Neoplasms |
Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants Reproductive Control Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |