Phentermine/Gastric Band Weight Loss Study

Obesity Clinical Trial

Official title:

Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00771654
• Other study ID #: 07-08-01A
• Status: Withdrawn
• Phase: N/A
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2012
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Phentermine
Subjects will receive Phentermine 37.5mg everyday for one year

Other:
• Placebo
daily for one year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes are total weight loss and excess weight		one year
Secondary	Secondary outcomes is resolution of preoperative comorbidities		one year