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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

PHRR200713-002750

3071-305-020

2020-CT0532

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

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.

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

Pending

Pending complete RA and EC approvals required for site initiation

Institution Classification Region LTO #
Allergan Limited Private Business United Kingdom
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR LTO-30000062581
Institution Region
Allergan Limited United Kingdom
Name E-Mail Institution and Institution Address
Sophie Choi Sophie.Choi@allergan.com Seocho-gu, Seoul 06615, Korea
Name E-Mail Institution and Institution Address
Wes Bochenek Wieslaw.Bochenek@Allergan.com Madison, NJ, USA
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 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

Diabetic Gastroparesis

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

Unspecified

Pending

  • 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

Clinical Trial

3071-305-020

20200320094838

2020-06-11

0000-00-00

15

Unspecified

Unspecified

13 Oct 2020

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.

Interventional

Relamorelin

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.

None

Randomized

N/A

Unspecified

Not Applicable

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

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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