ClinicalTrials.gg
WithdrawnNCT00771654Updated Apr 21, 2022

Phentermine/Gastric Band Weight Loss Study

An interventional study of Phentermine and Placebo in Obesity, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Low enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

Browse Obesity studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult age 18-65
  • BMI 35-55
  • Approved for gastric band operation

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    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

    Other: Placebo

  • Experimental
    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

    Drug: Phentermine

Interventions

  • Subjects will receive Phentermine 37.5mg everyday for one year

    Also known as: Adipex

  • OtherPlacebo

    daily for one year

06

What researchers measure

Primary outcomes

  1. Primary outcomes are total weight loss and excess weight

    Time frame: one year

Secondary outcomes

  1. Secondary outcomes is resolution of preoperative comorbidities

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2008
First posted
Oct 13, 2008
Start
Feb 2009
Primary completionActual
Sep 2010
CompletionActual
Sep 2010
Last update
Apr 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00771654
Responsible party
Sponsor
First posted
Oct 13, 2008
Start date
Feb 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Apr 21, 2022

Study contacts

Keith Gersin, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Phentermine

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