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Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00637572
First received: March 11, 2008
Last updated: September 14, 2016
Last verified: August 2016
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Cachexia
Anorexia
AIDS Wasting Syndrome
HIV Wasting Syndrome
Interventions: Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Megestrol Acetate Oral Suspension Nanocrystal Dispersion Subjects were treated with 575 mg per day as single-dose for 12 weeks
Megestrol Acetate Oral Suspension Micronized Formulation Subjects were treated with 800 mg per day as single-dose for 12 weeks

Participant Flow:   Overall Study
    Megestrol Acetate Oral Suspension Nanocrystal Dispersion   Megestrol Acetate Oral Suspension Micronized Formulation
STARTED   32   31 
COMPLETED   29   24 
NOT COMPLETED   3   7 
Adverse Event                1                2 
Death                0                1 
Lost to Follow-up                0                1 
Physician Decision                1                1 
Withdrawal by Subject                0                2 
Illicit Drug Use                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on Intend to Treat (ITT) population; all randomized subjects who were dispensed medication and had at least one post-randomization visit.

Reporting Groups
  Description
Megestrol Acetate Oral Suspension Nanocrystal Dispersion Subjects were treated with 575 mg per as single-dose for 12 weeks
Megestrol Acetate Oral Suspension Micronized Formulation Subjects were treated with 800 mg per as single-dose for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Megestrol Acetate Oral Suspension Nanocrystal Dispersion   Megestrol Acetate Oral Suspension Micronized Formulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   31   63 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (7.32)   36.3  (7.22)   36.8  (7.23) 
Gender 
[Units: Participants]
     
Female   11   16   27 
Male   21   15   36 


  Outcome Measures
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1.  Primary:   Change in Body Weight   [ Time Frame: Baseline (Day 1) to Week 12 ]

2.  Secondary:   Change From Baseline in Lean Mass   [ Time Frame: Baseline (Day 1) to Week 12 ]

3.  Secondary:   Change From Baseline in Impedance   [ Time Frame: Baseline (Day 1) to Week 12 ]

4.  Secondary:   Change From Baseline in Body Fat Mass   [ Time Frame: Baseline (Day 1) to Week 12 ]

5.  Secondary:   Change in Hip Circumference   [ Time Frame: Baseline (Day 1) to Week 12 ]

6.  Secondary:   Change in Waist Circumference   [ Time Frame: Baseline (Day 1) to Week 12 ]

7.  Secondary:   Change in Tricep Skinfold   [ Time Frame: Baseline (Day 1) to Week 12 ]

8.  Secondary:   Change in Mid-arm Circumference   [ Time Frame: Baseline (Day 1) to Week 12 ]

9.  Secondary:   Change in Total Energy   [ Time Frame: Baseline (Day 1) to Week 12 ]

10.  Secondary:   Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)   [ Time Frame: Baseline (Day 3) to Week 12 ]

11.  Secondary:   Appetite at Baseline (Day 3) and Week 12   [ Time Frame: Baseline (Day 3) to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
e-mail: clinicalsite.inquiries@endo.com


Publications of Results:
Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216


Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00637572     History of Changes
Other Study ID Numbers: PAR-002
Study First Received: March 11, 2008
Results First Received: January 29, 2016
Last Updated: September 14, 2016
Health Authority: United States: Food and Drug Administration