Phentermine/Gastric Band Weight Loss Study
Primary Purpose
Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phentermine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Adult age 18-65
- BMI 35-55
- Approved for gastric band operation
Exclusion Criteria:
- A known allergy to Phentermine
- Take medications for Attention Deficit Disorder (ADD)
- Monoamine oxidase inhibitors (MAOI)for depression
- Selective serotonin reuptake inhibitor (SSRIs)for depression
- History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
- Hyperthyroidism
- Glaucoma
- Psychosis
- History of drug abuse
- Uncontrolled hypertension (diastolic >85)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Phentermine
Arm Description
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
Outcomes
Primary Outcome Measures
Primary outcomes are total weight loss and excess weight
Secondary Outcome Measures
Secondary outcomes is resolution of preoperative comorbidities
Full Information
NCT ID
NCT00771654
First Posted
October 10, 2008
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00771654
Brief Title
Phentermine/Gastric Band Weight Loss Study
Official Title
Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Low enrollment
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
Arm Title
Phentermine
Arm Type
Experimental
Arm Description
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
Intervention Type
Drug
Intervention Name(s)
Phentermine
Other Intervention Name(s)
Adipex
Intervention Description
Subjects will receive Phentermine 37.5mg everyday for one year
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
daily for one year
Primary Outcome Measure Information:
Title
Primary outcomes are total weight loss and excess weight
Time Frame
one year
Secondary Outcome Measure Information:
Title
Secondary outcomes is resolution of preoperative comorbidities
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult age 18-65
BMI 35-55
Approved for gastric band operation
Exclusion Criteria:
A known allergy to Phentermine
Take medications for Attention Deficit Disorder (ADD)
Monoamine oxidase inhibitors (MAOI)for depression
Selective serotonin reuptake inhibitor (SSRIs)for depression
History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
Hyperthyroidism
Glaucoma
Psychosis
History of drug abuse
Uncontrolled hypertension (diastolic >85)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Gersin, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phentermine/Gastric Band Weight Loss Study
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