Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Qsymia as an Adjunct to Surgical Therapy in the Superobese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obesity
Metabolic Surgery
Weight Loss
Bariatric Surgery Procedures
Interventions Drug: Phentermine/topiramate
Other: low calorie diet
Enrollment 25
Recruitment Details Retrospective chart review patients were not considered enrolled, but historical data was used as a comparison so it is included.
Pre-assignment Details  
Arm/Group Title Phentermine/Topiramate Historical Control
Hide Arm/Group Description

All subjects enrolled in the study will be placed on the study medication.

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.

Retrospective chart review of patients who had sleeve gastrectomy without phentermine/topiramate
Period Title: Overall Study
Started 25 40
Completed 15 40
Not Completed 10 0
Arm/Group Title Phentermine/Topiramate Surgery Only Total
Hide Arm/Group Description

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had sleeve gastrectomy without phentermine/topiramate Total of all reporting groups
Overall Number of Baseline Participants 15 40 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 40 participants 55 participants
43.4  (7.3) 45  (10.8) 44.6  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 40 participants 55 participants
Female
12
  80.0%
33
  82.5%
45
  81.8%
Male
3
  20.0%
7
  17.5%
10
  18.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 40 participants 55 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
40
 100.0%
55
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 40 participants 55 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
03
  20.0%
9
  22.5%
12
  21.8%
White
12
  80.0%
31
  77.5%
43
  78.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 40 participants 55 participants
15 40 55
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 15 participants 40 participants 55 participants
178.9  (31.1) 159.5  (21) 164.8  (25.4)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 40 participants 55 participants
61.2  (7.1) 57  (5.6) 58.1  (6.3)
1.Primary Outcome
Title Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
Hide Description 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.
Time Frame 24 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of Sleeve Gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Measure Type: Count of Participants
Unit of Measure: Participants
8
  61.5%
19
  47.5%
2.Secondary Outcome
Title Percent Weight Change
Hide Description Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame Pre-operatively and 24 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: Percentage of weight change
-38.16
(-45.39 to -30.94)
-27
(-31.02 to -22.99)
3.Secondary Outcome
Title Body Mass Index
Hide Description Resulting body mass index
Time Frame 24 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of Sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
33.79
(29.47 to 38.12)
41.96
(39.47 to 44.45)
4.Secondary Outcome
Title Percent Body Fat
Hide Description Change in percent body fat
Time Frame 24 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not obtained
Arm/Group Title Phentermine/Topiramate Historical Control
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Resting Metabolic Rate
Hide Description Resting metabolic rate via indirect calorimetry
Time Frame 24 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not obtained
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percent Weight Change
Hide Description Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame Pre-operatively and 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: Percent
-39.34
(-45.36 to -33.32)
-31.43
(-34.86 to -28.01)
7.Secondary Outcome
Title Percent Weight Change
Hide Description Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame Pre-operatively and 6 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: Percent
-32.79
(-37.56 to -28.02)
-27.25
(-29.97 to -24.53)
8.Secondary Outcome
Title Percent Weight Change
Hide Description Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame Pre-operatively and 3 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: Percent
-25.24
(-29.63 to -20.84)
-21.46
(-23.96 to -18.97)
9.Secondary Outcome
Title Body Mass Index
Hide Description Resulting body mass index
Time Frame 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of Sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
33.46
(29.94 to 36.98)
39.53
(37.43 to 41.63)
10.Secondary Outcome
Title Body Mass Index
Hide Description Resulting body mass index
Time Frame 6 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of Sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
37.61
(34.83 to 40.38)
41.93
(40.23 to 43.63)
11.Secondary Outcome
Title Body Mass Index
Hide Description Resulting body mass index
Time Frame 3 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had RYGB instead of Sleeve gastrectomy
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 13 40
Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
42.31
(39.78 to 44.84)
45.28
(43.71 to 46.84)
12.Secondary Outcome
Title Percent Body Fat
Hide Description Change in percent body fat
Time Frame 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not obtained
Arm/Group Title Phentermine/Topiramate Historical Control
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Percent Body Fat
Hide Description Change in percent body fat
Time Frame 6 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not obtained
Arm/Group Title Phentermine/Topiramate Historical Control
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Percent Body Fat
Hide Description Change in percent body fat
Time Frame 3 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not obtained
Arm/Group Title Phentermine/Topiramate Historical Control
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Resting Metabolic Rate
Hide Description Resting metabolic rate via indirect calorimetry
Time Frame 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not obtained
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Resting Metabolic Rate
Hide Description Resting metabolic rate via indirect calorimetry
Time Frame 6 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not obtained
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Resting Metabolic Rate
Hide Description Resting metabolic rate via indirect calorimetry
Time Frame 3 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not obtained
Arm/Group Title Phentermine/Topiramate Surgery Only
Hide Arm/Group Description:

All subjects enrolled in the study will be placed on the study medication.

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.

Historical controls who had surgery only
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description Adverse events ascertained at each clinical follow up. Retrospective chart review patients were not considered enrolled, so adverse event information was not collected for them.
 
Arm/Group Title Phentermine/Topiramate
Hide Arm/Group Description

All subjects enrolled in the study will be placed on the study medication.

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.

All-Cause Mortality
Phentermine/Topiramate
Affected / at Risk (%)
Total   0/25 (0.00%)    
Hide Serious Adverse Events
Phentermine/Topiramate
Affected / at Risk (%) # Events
Total   2/25 (8.00%)    
Infections and infestations   
Panniculitis   1/25 (4.00%)  1
Psychiatric disorders   
Suicidal ideation *  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phentermine/Topiramate
Affected / at Risk (%) # Events
Total   3/25 (12.00%)    
Nervous system disorders   
insomnia   1/25 (4.00%)  1
Psychiatric disorders   
irritability   1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia   1/25 (4.00%)  1
Indicates events were collected by systematic assessment

This was an open-label, nonrandomized observational trial of only 2 years postoperative follow-up.

We also did not control for the amount of contact that patients received in the course of their treatment.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jamy Ard
Organization: Wake Forest School of Medicine
Phone: 336-716-9837
EMail: jard@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02301416    
Other Study ID Numbers: IRB00027047
First Submitted: November 21, 2014
First Posted: November 25, 2014
Results First Submitted: July 5, 2019
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019