Clincosm LogoSign in Get a demo

Phentermine/Gastric Band Weight Loss Study

Sponsor
Atrium Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00771654
Collaborator
(none)
0
Enrollment
2
Arms
19
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary outcomes are total weight loss and excess weight [one year]

    Secondary Outcome Measures

    1. Secondary outcomes is resolution of preoperative comorbidities [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Atrium Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keith Gersin, Chief of Bariatric Surgery at Carolinas Medical Center, Atrium Health
    ClinicalTrials.gov Identifier:
    NCT00771654
    Other Study ID Numbers:
    • 07-08-01A
    First Posted:
    Oct 13, 2008
    Last Update Posted:
    Aug 31, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Weight Loss
    Phentermine

    Study Results

    No Results Posted as of Aug 31, 2012