ObesityNCT00771654
Phentermine/Gastric Band Weight Loss Study
A study testing Phentermine in people with Obesity, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Phentermine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age 18-65
- BMI 35-55
- Approved for gastric band operation
Who cannot join
- 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
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- Glaucoma
- Psychosis
- History of drug abuse
- Uncontrolled hypertension (diastolic >85)
About this study
Official title: Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
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.
- Conditions
- Obesity
- Being tested
- Phentermine, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentermineDrug
Also called Adipex
Subjects will receive Phentermine 37.5mg everyday for one year
PlaceboOther
daily for one year
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Phentermine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes are total weight loss and excess weight
Measured: one year
Secondary outcomes (1)
Secondary outcomes is resolution of preoperative comorbidities
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Gersin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771654
- Sponsor's protocol ID
- 07-08-01A
- Status last verified
- Aug 2012
- First submitted
- 10 Oct 2008
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
- ClinicalTrials.gov ID
- NCT00771654
- Acronym / sponsor ID
- 07-08-01A
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects 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 | Experimental | Drug: PhentermineSubjects 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age 18-65
- BMI 35-55
- Approved for gastric band operation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhentermineAlso: AdipexSubjects will receive Phentermine 37.5mg everyday for one year | Drug | Phentermine |
| Placebodaily for one year | Other | Placebo |
Primary outcome
Primary outcomes are total weight loss and excess weight
Time frame: one year
1 secondary outcome
Secondary outcomes is resolution of preoperative comorbidities
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Gersin, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Phentermine in people with Obesity, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcomes are total weight loss and excess weight (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.