Diabetic gastroparesis research study with Relamoreli

Phase 1

• Conditions: Diabetic Gastroparesis; MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-000406-30-BG
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-30
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified