Phentermine/Gastric Band Weight Loss Study

April 19, 2022 updated by: Wake Forest University Health Sciences

Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
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
Other: Placebo
daily for one year
EXPERIMENTAL: Phentermine
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
Drug: Phentermine
Subjects will receive Phentermine 37.5mg everyday for one year
Other Names:
  • Adipex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary outcomes are total weight loss and excess weight
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes is resolution of preoperative comorbidities
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (ESTIMATE)

October 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-08-01A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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