Phentermine/Gastric Band Weight Loss Study

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Obesity

Treatments: Other: Placebo; Drug: Phentermine

Study type: Interventional

Funder types: Other

Identifiers

NCT00771654

07-08-01A

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Phentermine

Experimental group

Description:

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

Treatment:

Drug: Phentermine