Status:
COMPLETED
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
VIVUS LLC
Conditions:
Obesity
Metabolic Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 sur...
Detailed Description
While there is obvious focus on the obesity epidemic that affects approximately one-third of the U.S. population, one subgroup within the epidemic remains on the fringe of scientific study and effecti...
Eligibility Criteria
Inclusion
- BMI ≥ 50 kg/m2
- Determined to be a good candidate for surgery based on medical and psychological exam.
- Willing to participate in a 3-6 month medically supervised weight loss plan prior to surgery.
- Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health - Weight Management Center for the duration of the study.
Exclusion
- History of prior weight loss surgery (removal/conversion from band to sleeve will not be excluded)
- Pregnant (women of childbearing potential will complete a pregnancy test (blood draw) to make sure they are not pregnant at the time that they initiate the medication). Ongoing monitoring of pregnancy status is the responsibility of the patient and they are instructed as such in the consent form.
- Ongoing use of weight loss medication
- Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable cardiac disease (unstable angina, recent heart attack or stroke (in the past 6 months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like phentermine.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02301416
Start Date
December 1 2014
End Date
June 27 2018
Last Update
September 4 2019
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157