Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2009-02-28
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
Placebo
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
Phentermine
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
Placebo
daily for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 35-55
* Approved for gastric band operation
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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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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