This trial is active, not recruiting.

Condition obesity
Treatments phentermine-topiramate, matched-placebo
Phase phase 4
Sponsor Mayo Clinic
Start date April 2013
End date March 2014
Trial size 24 participants
Trial identifier NCT01834404, 13-000948


Our overall goal is to determine the effect of Phentermine and Topiramate on gastric emptying, gastric accommodation, and satiety and satiation in obese participants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Qualifying participants will be assigned either Phentermine-Topiramate or placebo for a minimum of 5 days.
Qualifying participants will be assigned to either Phentermine-Topiramate or placebo for a minimum of 5 days.
(Placebo Comparator)
Qualifying participants will be assigned to Phentermine-Topiramate or placebo for a minimum of 5 days.
matched-placebo Placebo
Qualifying participants will be assigned to either Phentermine-Topiramate or placebo for a minimum of 5 days.

Primary Outcomes

Evaluate the effect of Phentermine-Topiramate vs placebo on gastric function and satiation in obese participants.
time frame: Up to 30 days

Secondary Outcomes

Evaluate the secondary effects of Phentermine-Topiramate vs placebo in gastric transit, satiety and meal preferences in obese participants.
time frame: Up to 30 days

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

INCLUSION CRITERIA - Obese subjects with BMI> 30 Kg/m2: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease. - Age: 18-70 years - Gender: Men or women. Women of childbearing potential will have negative pregnancy test before initiation of medication. EXCLUSION CRITERIA - Weight >300 lbs which is the limit of safety for the SPECT scanner - Concomitant use of appetite suppressants (i.e. caffeine based or diethylpropion) or orlistat (Xenical®) - Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg) - Concentration of fasting glucose greater than 240 mg/dl - Concentration of triglycerides greater than 400 mg/dl - Type 1 Diabetes - use of anti-diabetic drugs other than metformin, - history of nephrolithiasis, - recurrent major depression, presence or history of suicidal behaviour or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire [PHQ-9]21 total score ≥10). - Concomitant use of MAOI inhibitors (i.e. phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants - Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale [HADS] self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. - End stage renal disease or liver cirrhosis - Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e. ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.

Additional Information

Official title Peripheral Pharmacodynamics of Topiramate-Phentermine in Obese Patients
Principal investigator Michael Camilleri, MD
Description Investigators propose a randomized controlled trial of combination phentermine topiramate versus placebo given orally for 10-15 days. Dosing of 3.75/23 mg days 1-5, increased to 7.5/46 mg days 6-14. Participants will be randomized according to a computer generated randomization schedule generated by the study statistician's office and submitted to the Mayo Clinic CTSA research pharmacy. Allocation will be concealed. The study blind will be retained until all the data on gastric emptying, accommodation, satiation and satiety have been recorded and transmitted to the statistician for data lock.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.