Phentermine/Gastric Band Weight Loss Study | NCT00771654

Studies
Phentermine/Gastric Band Weight Loss Study

NCT00771654

Sponsor

Wake Forest University Health Sciences

Status

Withdrawn

Last Update Posted

Apr 21, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Phentermine
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 10, 2008

First Submission Date that Met QC Criteria

Oct 10, 2008

First Posted Date

Oct 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	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	Other: Placebo
Phentermine	Experimental	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	Drug: Phentermine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phentermine	Drug	Subjects will receive Phentermine 37.5mg everyday for one year	Phentermine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcomes are total weight loss and excess weight		one year

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes is resolution of preoperative comorbidities		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith Gersin, MD	Wake Forest University Health Sciences	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010645	Phentermine

Ancestor Terms

ID	Term
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930

Browse Leaves

Not provided

Browse Branches

Not provided