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Qsymia as an Adjunct to Surgical Therapy in the Superobese

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ClinicalTrials.gov Identifier: NCT02301416
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
VIVUS, Inc.
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE November 25, 2014
Results First Submitted Date  ICMJE July 5, 2019
Results First Posted Date  ICMJE September 4, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) [ Time Frame: 24 months post-operatively ]
Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Roux en Y Gastric Bypass [ Time Frame: 24 months post-operatively ]
Proportion of patients to meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Percent Weight Change [ Time Frame: Pre-operatively and 24 months post-operatively ]
    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
  • Body Mass Index [ Time Frame: 24 months post-operatively ]
    Resulting body mass index
  • Percent Body Fat [ Time Frame: 24 months post-operatively ]
    Change in percent body fat
  • Resting Metabolic Rate [ Time Frame: 24 months post-operatively ]
    Resting metabolic rate via indirect calorimetry
  • Percent Weight Change [ Time Frame: Pre-operatively and 12 months post-operatively ]
    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
  • Percent Weight Change [ Time Frame: Pre-operatively and 6 months post-operatively ]
    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
  • Percent Weight Change [ Time Frame: Pre-operatively and 3 months post-operatively ]
    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
  • Body Mass Index [ Time Frame: 12 months post-operatively ]
    Resulting body mass index
  • Body Mass Index [ Time Frame: 6 months post-operatively ]
    Resulting body mass index
  • Body Mass Index [ Time Frame: 3 months post-operatively ]
    Resulting body mass index
  • Percent Body Fat [ Time Frame: 12 months post-operatively ]
    Change in percent body fat
  • Percent Body Fat [ Time Frame: 6 months post-operatively ]
    Change in percent body fat
  • Percent Body Fat [ Time Frame: 3 months post-operatively ]
    Change in percent body fat
  • Resting Metabolic Rate [ Time Frame: 12 months post-operatively ]
    Resting metabolic rate via indirect calorimetry
  • Resting Metabolic Rate [ Time Frame: 6 months post-operatively ]
    Resting metabolic rate via indirect calorimetry
  • Resting Metabolic Rate [ Time Frame: 3 months post-operatively ]
    Resting metabolic rate via indirect calorimetry
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • Percent weight loss [ Time Frame: Pre-operatively and 24 months post-operatively ]
    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
  • Percent Body Fat [ Time Frame: Pre-operatively and 24 months post-operatively ]
    Change in percent body fat both before and after surgery.
  • Resting Metabolic Rate [ Time Frame: pre-operatively and 24 months post-operatively ]
    Change in resting metabolic rate during the pre-operative period and 24 months post-operatively.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qsymia as an Adjunct to Surgical Therapy in the Superobese
Official Title  ICMJE Qsymia as an Adjunct to Surgical Therapy in the Superobese
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 surgery will be compared to historical controls who had surgery without taking the medication.
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 effective treatment options. The super obese patient, in this instance defined as those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40 kg/m2), the risks involved with surgical intervention in the super obese patient are high.

Qsymia provides a potential opportunity to develop an effective treatment plan that would be an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to surgical intervention, lowering surgical risk to some extent. Additionally, if continued post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially extend the weight loss horizon so that the probability of the typical weight loss plateau at 12-18 months is decreased.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Metabolic Surgery
  • Weight Loss
  • Bariatric Surgery Procedures
Intervention  ICMJE
  • Drug: Phentermine/topiramate
    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.
    Other Name: Qsymia
  • Other: low calorie diet
    The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Study Arms  ICMJE
  • Experimental: Phentermine/topiramate
    All subjects enrolled in the study will be placed on the study medication.
    Interventions:
    • Drug: Phentermine/topiramate
    • Other: low calorie diet
  • No Intervention: Historical Control
    Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2014)
20
Actual Study Completion Date  ICMJE June 27, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02301416
Other Study ID Numbers  ICMJE IRB00027047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE VIVUS, Inc.
Investigators  ICMJE
Principal Investigator: Jamy D Ard, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP