Status:
COMPLETED
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado- Clinical and Translational Sciences Institute
Conditions:
Obesity, Morbid
Bariatric Surgery
Eligibility:
All Genders
12-24 years
Phase:
PHASE2
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 reductio...
Eligibility Criteria
Inclusion
- Status post sleeve gastrectomy or roux-en-y gastric bypass
- At 6 months after bariatric surgery, has not achieved \>= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (\>=120% of 95th%ile or BMI \>=35kg/m2 for 12-17yo; BMI \>=35kg/m2 for 18-24yo)
Exclusion
- Absolute contraindication to phentermine or topiramate (i.e. phentermine:
- history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)
- Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
- Use of anti-obesity medication within 6 months of screening
- Initiation of a new medication associated with weight loss or gain within 30 days of screening
- Type 2 diabetes mellitus
- Hypothalamic obesity
- Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
- History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
- History of schizophrenia
- Severe hepatic impairment (ALT \>10x upper limit of normal or known synthetic liver dysfunction)
- Moderate or severe renal impairment (GFR \<30mL/min/1.73m2)
- Dosage change to hypertension, dyslipidemia, depression, or anxiety medication \<4 weeks prior to study enrollment
- Contraception started \<7 days prior to study enrollment
- Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
- Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04095104
Start Date
January 15 2020
End Date
January 25 2022
Last Update
May 23 2025
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045