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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Status: Withdrawn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

Page last updated: August 23, 2015

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