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Phentermine/Gastric Band Weight Loss Study

This study has been withdrawn prior to enrollment.
(Low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771654
First Posted: October 13, 2008
Last Update Posted: August 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Keith Gersin, Carolinas Healthcare System
  Purpose
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 Intervention
Obesity Drug: Phentermine Other: Placebo

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Keith Gersin, Carolinas Healthcare System:

Primary Outcome Measures:
  • Primary outcomes are total weight loss and excess weight [ Time Frame: one year ]

Secondary Outcome Measures:
  • Secondary outcomes is resolution of preoperative comorbidities [ Time Frame: one year ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Adipex

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Keith Gersin, Chief of Bariatric Surgery at Carolinas Medical Center, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00771654     History of Changes
Other Study ID Numbers: 07-08-01A
First Submitted: October 10, 2008
First Posted: October 13, 2008
Last Update Posted: August 31, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action