A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

TerminadoFase 3ClinicalTrials.gov

ID: NCT03420781Tipo: INTERVENTIONALInicio: 24 de ene de 2018Fin estimado: 30 de oct de 2020

Traducción no disponible, mostrando original

Resumen

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all the following criteria apply:

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

Intervenciones

drug

Placebo

Placebo injected twice daily

drug

Relamorelin

Relamorelin 10 μg injected twice daily

Ubicaciones

Maffei Centro Medico-Investigacion Clinica Aplicada

C.a.b.a., Buenos Aires, Argentina

Hospital Sirio Libanes

CABA, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Privado de Investigaciones Clínicas de Córdoba

Córdoba, Córdoba Province, Argentina

Instituto de Investigaciones Clinicas de Rosario

Rosario, Santa Fe Province, Argentina

Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

Rosario, Santa Fe Province, Argentina

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

CIPREC

Buenos Aires, Argentina

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, Argentina

Patrocinadores

PrincipalAllergan

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