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NCT00115063 · ClinicalTrials.gov registry record · Phase 4
LOSS- Louisiana Obese Subjects Study
A Phase 4 study, sponsored by Pennington Biomedical Research Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 390
- Enrollment target
NCT00115063: Clinical Trial Phase 4 study, sponsored by Pennington Biomedical Research Center.
NCT00115063 is a Phase 4 study that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 390 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00115063, a Phase 4 study, was terminated before completion, sponsored by Pennington Biomedical Research Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 390 participants
- Enrollment target
Study Summary
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index \[BMI\] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.
Interventions
- OTHER Control Condition
- BEHAVIORAL group sessions
- DRUG sibutramine, orlistat, diethylpropion
- BEHAVIORAL Low Calorie Diet, Health One
- OTHER Intensive Medical Combination Therapy for Obesity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2005-07 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
Why NCT00115063 stopped before completion
NCT00115063 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Control Condition is the first listed.
NCT00115063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00115063 about?
NCT00115063 is a clinical study titled "LOSS- Louisiana Obese Subjects Study". LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index \[BMI\] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseli...
What is the current status of trial NCT00115063?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 390 participants. The study started on 2005-07. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00115063?
The interventions under investigation include: Control Condition (OTHER), group sessions (BEHAVIORAL), sibutramine, orlistat, diethylpropion (DRUG), Low Calorie Diet, Health One (BEHAVIORAL), Intensive Medical Combination Therapy for Obesity (OTHER).
Who is sponsoring clinical trial NCT00115063?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00115063's enrollment target sits among peer trials
390 221st of 2000 higher than 1,779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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