Fixed Dose Combination of Fluoxetin and Metformin in the Management of Overweight and Obesity
Status:
Suspended
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel
groups, randomized treatment to assess the efficacy and safety using a fixed dose combination
of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or
overweight in order to generate new knowledge and give a greater number of therapeutic
options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine;
Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group
called control will receive placebo.
The above described treatments will be administered according to the "Dosage Schedule" The
three groups will receive tablets of physical characteristics equal to the reference drug to
preserve the blinding.
Phase:
Phase 2
Details
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Collaborators:
IBIOMED INVESTIGACIÓN BIOMÉDICA PARA EL DESARROLLO DE FÁRMACOS, S.A. DE C.V. INTEC Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara. OSMO (OAXACA SITE MANAGEMENT ORGANIZATION, SC)