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Phentermine/Gastric Band Weight Loss Study

Primary Purpose

Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phentermine
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 10, 2008
    Last Updated
    April 19, 2022
    Sponsor
    Wake Forest University Health Sciences
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    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    Withdrawn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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