Phentermine/Gastric Band Weight Loss Study
Information source: Carolinas Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Phentermine (Drug); Placebo (Other)
Phase: N/A
Status: Withdrawn
Sponsored by: Carolinas Healthcare System
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.
Clinical Details
Official title: Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Primary outcomes are total weight loss and excess weight
Secondary outcome: Secondary outcomes is resolution of preoperative comorbidities
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Starting date: February 2009
Last updated: August 30, 2012
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