Phentermine/Gastric Band Weight Loss Study

NCT ID: NCT00771654

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

daily for one year

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

Group Type EXPERIMENTAL

Phentermine

Intervention Type DRUG

Subjects will receive Phentermine 37.5mg everyday for one year

Interventions

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Phentermine

Subjects will receive Phentermine 37.5mg everyday for one year

Intervention Type DRUG

Placebo

daily for one year

Intervention Type OTHER

Other Intervention Names

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Adipex

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Gersin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

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07-08-01A

Identifier Type: -

Identifier Source: org_study_id

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