Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients

Phase 4 Completed 24 enrolled Mayo Clinic National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2013-04
Primary completion: 2014-03
Completion: 2014-03

Outcome

Mixed primary results

registry MEAN Phentermine-Topiramate ER: 109 (Standard Error 7) minutes MEAN Placebo: 88 (Standard Error 7) minutes analysis (superiority or other test); Phentermine-Topiramate ER vs Placebo; p = 0.057; ANCOVA NCT01834404 ↗

registry MEAN Phentermine-Topiramate ER: 728 (Standard Error 79) Kcal MEAN Placebo: 988 (Standard Error 79) Kcal analysis (superiority or other test); Phentermine-Topiramate ER vs Placebo; p = 0.032; ANCOVA NCT01834404 ↗

Publications

Results Acosta A, Camilleri M, Shin A, Vazquez-Roque MI, Iturrino J, Burton D, O'Neill J, Eckert D, Zinsmeister AR. Quantitative gastrointestinal and psychological traits associated with obesity and response to weight-loss therapy. Gastroenterology. 2015 Mar;148(3):537-546.e4. doi: 10.1053/j.gastro.2014.11.020. Epub 2014 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentermine	Small molecule	7.5 mg	Oral
Subject	Topiramate	Small molecule	46 mg	Oral