Submitted by: Geraldine Guerina 2020-07-09 05:21:28 Last Updated by: Principe, Jeverly Ann S 2020-07-13 18:21:54

Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

Registry ID

PHRR200713-002750

Secondary Identification Number

3071-305-020

FDA Clinical Trial Reference (CTR) Number

2020-CT0532

Scientific Title

Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

Project Description

Study 3071-305-020 is an open-label, multicenter, multinational safety study in participants with Diabetic Gastroparesis (DG) who completed the Phase 3 studies, RLM-MD-03 or RLM-MD-04. Participants who discontinued Studies RLM-MD-03 or RLM-MD-04 for any reason are not to be enrolled into this study. Participants who roll over to this continued-access study within 30 days (ie, ≤ 30 days) of completing their final visit assessments in either Study RLM-MD-03 or Study RLM-MD-04 do not need to complete baseline assessments; information from the final visit of studies RLM-MD-03 or RLM-MD-04 will be used as the information for Visit 1 of this study.

Project Duration

Start Date	Duration in Months	Target Completion Date	Actual Completion Date
2020-10-13	47	2024-09-13	0000-00-00

Project Status

Pending

Reason for project pending/suspension/termination

Pending complete RA and EC approvals required for site initiation

Implementing Agency (Primary Sponsor)

Institution	Classification	Region	LTO #
Allergan Limited	Private Business	United Kingdom

Cooperating Agency (Secondary Sponsor)

Institution	Classification	Region	LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp.	Private Business	NCR	LTO-30000062581

Funding Agency (Sources of Monetary or Material Support)

Institution	Region
Allergan Limited	United Kingdom

Contact for Public Queries

Name	E-Mail	Institution and Institution Address
Sophie Choi	Sophie.Choi@allergan.com	Seocho-gu, Seoul 06615, Korea

Contact for Scientific Queries

Name	E-Mail	Institution and Institution Address
Wes Bochenek	Wieslaw.Bochenek@Allergan.com	Madison, NJ, USA

Investigating Team

Name	Expertise	Affiliation
Ernesto Ang, MD	Internal Medicine	Cardinal Santos Medical Center
Marsha Tolentino, MD	Internal Medicine	Perpetual Succour Hospital
Rosa Allyn G. Sy, MD	Internal Medicine	Ospital ng Makati

Project Location and Institutional Ethics Review Board

Project Location	Institutional Ethics Review Board
Cardinal Santos Medical Center	Cardinal Santos Medical Center Ethics Review Committee
Perpetual Succour Hospital	Perpetual Succour Hospital Institutional Ethics and Review Board
Ospital ng Makati	Ospital ng Makati Ethics Review Committee

Health Condition(s) or Problem(s) Studied

Diabetic Gastroparesis

Primary Outcomes

To assess the safety of continued tretment with RLM for participants who previously completed the RLM-MD-03 or RLM-MD-04 study

Key Secondary Outcomes

Unspecified

Recruitment Status

Pending

Countries of Recruitment

Argentina
Australia
Austria
Brazil
Bulgaria
Colombia
Denmark
France
Germany
Hungary
India
Israel
Latvia
Malaysia
Mexico
Philippines
Poland
Russia
Singapore
South Africa
South Korea
Spain
Thailand
Ukraine
United Kingdom
United States

Research Classification

Clinical Trial

FDA Document Tracking Number

20200320094838

FDA Approval Date

2020-06-11

ERC Approval Date

0000-00-00

Target Sample Size (Philippines)

Actual Sample Size (Philippines)

Unspecified

Reason for the difference between Target & Actual Sample Sizes

Unspecified

Date of First Enrollment

13 Oct 2020

Key Inclusion and Exlusion Criteria (CT)

Inclusion Criteria
1. Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 (completed final study visit), and rolling over into Study 3071-305-020 in ≤ 30 days; eligible participants who completed these studies prior to administrative initiation of this protocol at their study center, will also be allowed to participate in this continued-access study
2. Ability to provide written IC prior to any study procedures and willingness and ability to comply with study procedures
3. Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator

Exclusion Criteria
1. Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020.
2. Participant has an unresolved AE from a lead-in study that, in the investigator’s opinion, would limit the participant’s ability to participate in the study (see also Section 8).
3. 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
4. Females who are pregnant, nursing, or planning a pregnancy during the study
5. Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, sub-investigator, study coordinator, other study staff member, or employee of Allergan; 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.

Study Type

Interventional

Intervention Name

Relamorelin

Intervention Description

Relamorelin (also known as RM-131) is a novel, potent and selective synthetic penta-peptide ghrelin analogue, which is being developed for treatment of diabetic gastroparesis.

Amendment Approval Date/Reasons

None

Method of Allocation

Randomized

Masking / Blinding

N/A

Masking Details

Unspecified

Assignment

Not Applicable

Purpose

To assess the safety of continued tretment with RLM for participants who previously completed the RLM-MD-03 or RLM-MD-04 study

Phase

Phase III

Research Utilization

Utilization	Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others