Submitted by: Margarett Lerin 2018-12-04 00:00:00 Last Updated by: Margarett Lerin 2019-05-10 09:33:21 Export to PDF

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

PHRR181204-001992

RLM-MD-03

2018-CT0449

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

multicenter, double-blind, placebo-controlled, parallel-group study with a randomized-withdrawal period (RWP) Two treatment groups are planned: Relamorelin 10 μg or placebo, twice daily, SC

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-02-28 12 2020-02-28 0000-00-00

Pending

not yet started

Institution Classification Region LTO #
Allergan Ltd. Private Business United States of America N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Amount Region
Allergan Ltd. N/A United States of America
Name E-Mail Phone Number Postal Address
Teddy Dizon Teddy.Dizon@allergan.com +63-29104444 21st Floor Robinsons Cyberscape Beta Topaz & Rudy Roads, Ortigas Center PASIG, Manila, 1605 Philippines
Name E-Mail Phone Number Postal Address
MaryHazel Lauron maryhazel.lauron@allergan.com +63-29104444 21st Floor Robinsons Cyberscape Beta Topaz & Rudy Roads, Ortigas Center PASIG, Manila, 1605 Philippines
Name Expertise Affiliation
Rosa Allyn G. Sy, MD Principal Investigator Ospital ng Makati
Ernesto Ang, MD Principal Investigator Cardinal Santos Medical Center
Cecilia A. Jimeno, MD Principal Investigator San Juan De Dios Educational Foundation, Inc.,
Michael Lim Villa, MD Principal Investigator St. Luke's Medical Center - Quezon City
Aretha Ann Liwag, MD Principal Investigator West Visayas State University
Roberto C. Mirasol, MD Principal Investigator Manila Doctors Hospital
Marsha Tolentino, MD Principal Investigator Perpetual Succour Hospital
Project Location Institutional Ethics Review Board
Ospital ng Makati Ospital ng Makati Ethics Review Committee
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
San Juan De Dios Educational Foundation, Inc., N/A
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Committee
West Visayas State University West Visayas State University Unified Biomedical Research Ethics Review Committee
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board

Diabetic Gastroparesis

efiicacy of relamorelin with the placebo

Unspecified

Pending

Clinical Trial

20180629124756

2018-11-08

Date Amendment Classification Reason
2019-01-29 Amendments related to the trial arrangements Change of the trial site or addition of new site
2019-02-01 Amendments related to the protocol Informed consent
2019-05-02 Amendments related to the protocol Others

Inclusion Criteria:1.    Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 or Protocol RLM-MD-02 and successfully completed the study2.    Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures3.    In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in RLM-MD-01 or RLM-MD-02  Exclusion Criteria:1.    Participant is not willing or able to abide by the restrictions regarding concomitant medicine use2.    Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-033.    Participant has an unresolved AE or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead ECG that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete the study4.    A ny 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 disease5.    Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of Allergan, Inc.; or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site

Interventional

Relamorelin

Relamorelin 10 μg or placebo subcutaneously (SC) BID

Randomized

Double Blind

Unspecified

Parallel

•To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study   (Nausea, Abdominal pain, postprandial fullness, Bloating)•To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study

Phase III

35

Unspecified

Unspecified

28 Feb 2019

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