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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-01-25

Brief Summary

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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).

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Detailed Description

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Conditions

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Obesity, Morbid Bariatric Surgery Adolescent Young Adult Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Phentermine & Topiramate

Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration:

4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning

\+

Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning

\+

Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)

Group Type EXPERIMENTAL

Phentermine

Intervention Type DRUG

Phentermine tablet

Immediate Release Topiramate

Intervention Type DRUG

Topiramate tablet

Placebo Drugs

Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning

\+

Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning

\+

Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)

Group Type PLACEBO_COMPARATOR

Placebo for Phentermine

Intervention Type DRUG

Compounded tablet to mimic phentermine 8mg tablet

Placebo for Immediate Release Topiramate

Intervention Type DRUG

Compounded tablet to mimic immediate release topiramate 25mg tablet

Interventions

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Phentermine

Phentermine tablet

Intervention Type DRUG

Immediate Release Topiramate

Topiramate tablet

Intervention Type DRUG

Placebo for Phentermine

Compounded tablet to mimic phentermine 8mg tablet

Intervention Type DRUG

Placebo for Immediate Release Topiramate

Compounded tablet to mimic immediate release topiramate 25mg tablet

Intervention Type DRUG

Other Intervention Names

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Lomaira Adipex-P C045TQL4WP 2-methyl-1-phenylpropan-2-amine Topamax 0H73WJJ391 [(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No