Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

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).

Conditions

• Obesity, Morbid
• Bariatric Surgery
• Adolescent
• Young Adult
• Drug Therapy

Interventions

DRUG

Phentermine

Phentermine tablet

DRUG

Immediate Release Topiramate

Topiramate tablet

DRUG

Placebo for Phentermine

Compounded tablet to mimic phentermine 8mg tablet

DRUG

Placebo for Immediate Release Topiramate

Compounded tablet to mimic immediate release topiramate 25mg tablet

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Colorado- Clinical and Translational Sciences Institute

  collaborator UNKNOWN

• University of Colorado- Nutrition Obesity Research Center

  collaborator UNKNOWN

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Jaime M Moore, MD, MPH · University of Colorado School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-15

Primary Completion

2022-01-25

Completion

2022-01-25

FDA Drug

Yes

Countries

• United States

Study Locations