Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 10
Summary
- Conditions
- Adolescent
- Bariatric Surgery
- Drug Therapy
- Obesity Morbid
- Young Adult
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: At baseline, each participant will be randomized 1:1 to either 12 weeks of phentermine, topiramate and standard of care or 12 weeks of phentermine placebo, topiramate placebo, and standard of care. This randomization will be blinded to the participant, investigator, care providers, and outcomes assessor for the duration of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 24 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04095104
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Colorado- Clinical and Translational Sciences Institute
- University of Colorado- Nutrition Obesity Research Center
- Investigators
- Principal Investigator: Jaime M Moore, MD, MPH University of Colorado School of Medicine
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