Diabetic Gastroparesis MedDRA version: 20.1 Level: PT Classification code 10051153 Term: Diabetic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 or Protocol RLM-MD-02 and successfully completed the study 2. Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures 3. In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02 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 720 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: 1. Participant is not willing or able to abide by the restrictions regarding concomitant medicine use 2. Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03 3. 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 study 4. 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 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Change from Baseline to Week 12 of this study in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) • Vomiting Week-12 Responder, defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-week Treatment Period ;Timepoint(s) of evaluation of this end point: week 12;Main Objective: To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating. To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to vomiting frequency ;Secondary Objective: - To compare the efficacy of relamorelin with placebo after 12 weeks of treatment in this study in participants with DG with respect to the following individual symptoms of the DGSSS: nausea, abdominal pain, postprandial fullness, bloating - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to vomiting frequency - At the end of the 6-week randomized-withdrawal period (RWP), to demonstrate maintenance of efficacy among participants who were switched from relamorelin to placebo vs participants who continued relamorelin treatment To compare the safety of relamorelin with p | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Individual Symptom (ie, nausea, abdominal pain, postprandial fullness, and bloating) Week-12 Responder • Change from Baseline (CFB) to Week 40 in the average weekly DGSSS • Vomiting Frequency at Week 40 • CFB to Week 40 in the average weekly number of vomiting episodes • CFB to end of RWP in the average weekly DGSSS • CFB to end of RWP in the number of vomiting episodes • AEs, clinical laboratory values, vital signs, electrocardiograms (ECGs), HbA1c, and anti-relamorelin antibodies ;Timepoint(s) of evaluation of this end point: week 40 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Colombia, Denmark, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Malaysia, Mexico, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Thailand, Ukraine, United Arab Emirates, United Kingdom
Contacts
Public ContactAllergan Ltd EU Regulatory Dept.
Allergan Ltd.
Outcome results
None listed