Phentermine/Gastric Band Weight Loss Study

Overview

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.

Full Title of Study: “Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2010

Interventions

  • Drug: Phentermine
    • Subjects will receive Phentermine 37.5mg everyday for one year
  • Other: Placebo
    • daily for one year

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Keith Gersin, MD, Principal Investigator, Wake Forest University Health Sciences

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