NCT00637728|TerminatedPhase 3Results
Study Stopped
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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
Sponsor study identifier
interventional
5
1 country
3
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2006
Actual (reported)Study Completion
September 2006
Actual (reported)Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 2006
Actual (reported)September 2006
Actual (reported)March 11, 2008
Actual (reported)March 18, 2008
Actual (reported)February 29, 2016
Actual (reported)Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.
8 weeks
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
Baseline, Week 4 and Week 8
Change in Weight Over the Course of the 8-week Double-blind Phase
Baseline, Week 1, 2, 3, 4, 6, and 8
Megestrol acetate concentrated suspension 110 mg/mL
Placebo suspension
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
Placebo oral suspension, 5 mL once daily
Innovative Medical Research of South Florida, Inc
Miami, Florida, 33179, United States
Western Maryland Health System
Cumberland, Maryland, 21502, United States
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, 29464, United States
Lynn D Kramer, MD
Par Pharmaceutical, Inc.
John N Mehanna, MD
Western Maryland Health System
M.Daud Nawabi, MD
Lowcountry Hematology & Oncology, PA
Marc A Saltzman, MD
Innovative Medical Research of South Florida, Inc
5 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2008
First Posted
March 18, 2008
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
Baseline, Weeks 1, 2, 3, 4, 6 and 8
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 2006
Actual (reported)Study Completion
September 2006
Actual (reported)Last Updated
June 23, 2016
Results First Posted
February 29, 2016
Record last verified: 2016-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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