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NCT04095104 · ClinicalTrials.gov registry record · Phase 2
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04095104 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 13 participants.
The verdict
NCT04095104, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).
Interventions
- DRUG Phentermine
- DRUG Immediate Release Topiramate
- DRUG Placebo for Phentermine
- DRUG Placebo for Immediate Release Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2022-01-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04095104
The ClinicalTrials.gov registry entry for NCT04095104 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Phentermine is the first listed.
NCT04095104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04095104 about?
NCT04095104 is a clinical study titled "Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds". The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded desi...
What is the current status of trial NCT04095104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-01-15. Estimated completion is 2022-01-25.
What interventions are being tested in trial NCT04095104?
The interventions under investigation include: Phentermine (DRUG), Immediate Release Topiramate (DRUG), Placebo for Phentermine (DRUG), Placebo for Immediate Release Topiramate (DRUG).
Who is sponsoring clinical trial NCT04095104?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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