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Phentermine/Gastric Band Weight Loss Study

This study has been withdrawn prior to enrollment.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Keith Gersin, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00771654
First received: October 10, 2008
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Primary outcomes are total weight loss and excess weight [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes is resolution of preoperative comorbidities [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

No publications provided

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
Study First Received: October 10, 2008
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013