Phentermine/Gastric Band Weight Loss Study - Full Text View

Sponsor:	Carolinas Healthcare System
Information provided by:	Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT00771654

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:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Phentermine Phentermine hydrochloride

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 ]

Estimated Enrollment:	144
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771654

Locations

United States, North Carolina
Carolinas Weight Management and Wellness Center
Charlotte, North Carolina, United States, 28204

Sponsors and Collaborators

Carolinas Healthcare System

More Information

No publications provided

Responsible Party:	Keith Gersin, MD, 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:	June 23, 2011
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 February 09, 2012