Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT04095104
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2019-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P30DK048520-24 | NIH | None | https://reporter.nih.gov/quic… | View |