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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: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT04095104 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
(Number enrolled divided by number eligible) x 100
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 |
What the finished NCT04095104 record still lists
NCT04095104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Phentermine is the first listed.
NCT04095104 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04095104's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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