NCT00637806|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 Cancer of Multiple Types
Sponsor study identifier
interventional
4
1 country
4
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)To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
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)May 2, 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
Change in Weight Over the Course of the 8-week Double-blind Phase
Baseline, Week 1, 2, 3, 4, 6, and 8
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
Megestrol acetate concentrated suspension 110 mg/mL
Megestrol acetate concentrated suspension 60 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
Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, 28731, United States
Wake Forest University
High Point, North Carolina, 27262, United States
Summit Oncology Associates, Inc.
Akron, Ohio, 44304, United States
Lynn D Kramer, MD
Par Pharmaceutical, Inc.
Janet Bull, MD
Four Seasons Hospice and Paliative Care
Veena Charu, MD
Pacific Cancer Medical Center, Inc.
Bart Frizzell, MD
Wake Forest University, Dept of Radiation Oncology
4 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.
Baseline, Week 4 and Week 8
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
Placebo oral suspension, 5 mL once daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Mehool Patel, MD
Summit Oncology Associates, Inc.
Primary Completion
September 2006
Actual (reported)Study Completion
September 2006
Actual (reported)Last Updated
May 2, 2016
Results First Posted
May 2, 2016
Record last verified: 2016-03
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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