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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 is a Phase 4 study that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 390 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115063
The ClinicalTrials.gov registry entry for NCT00115063 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Control Condition is the first listed.
NCT00115063 reports 0 study locations.
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.
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