CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Phentermine/topiramate +1 moredrug
Likely dose
Phentermine/topiramate 46 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02301416
NCT02301416Phase 2Completed
CompareCT.gov

Qsymia as an Adjunct to Surgical Therapy in the Superobese

Wake Forest University Health Sciences·interventional·Posted Nov 25, 2014·Updated Sep 4, 2019

In Brief

A Phase 2 clinical trial evaluating Phentermine/topiramate and low calorie diet for Obesity and 3 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Metabolic Surgery, Weight Loss, Bariatric Surgery Procedures
CountriesUnited States
CollaboratorsVIVUS LLC

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 25, 2014
Enrollment StartDec 1, 2014
Primary CompletionJun 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.6 years ago

Interventions

Phentermine/topiramatedrug

Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.

low calorie dietother

The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.