CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL +1 moredrug
Likely dose
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00637572
NCT00637572Phase 2Completed
CompareCT.gov

A Randomized, Open-labeled, Pilot Study Comparing Weight Gain in Adults With AIDS-related Wasting Given Either Megestrol Acetate Oral Suspension Nanocrystal Dispersion (MA-NCD) or Megestrol Acetate Oral Suspension (Megace)

Endo Pharmaceuticals·interventional·Posted Mar 18, 2008·Updated Oct 5, 2017

In Brief

A Phase 2 clinical trial evaluating Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL and Megestrol acetate oral suspension 40 mg/mL for HIV Infections and 4 related conditions. Completed, enrolled 63 participants across 12 sites in 3 countries.

Detailed Summary

Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Cachexia, Anorexia, AIDS Wasting Syndrome, HIV Wasting Syndrome
CountriesIndia, South Africa, United States
CollaboratorsQuintiles, Inc.

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 18, 2008
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.3 years ago

Interventions

Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mLdrug

Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)

Megestrol acetate oral suspension 40 mg/mLdrug

Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)