Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03426345
• Date of registration: 02/02/2018
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02
• Scientific title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
• Date of first enrolment: February 16, 2018
• Target sample size: 311
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03426345
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Colombia, Denmark, Germany, Hungary, Latvia, Mexico, Puerto Rico, Romania, Russian Federation, South Africa, Ukraine, United Kingdom, United States

Contacts

• Name: Wieslaw (Wes) Bochenek, MD, PhD
• Affiliation: Allergan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Type 1 or Type 2 diabetes mellitus

- Meet the per protocol criteria of diabetic gastroparesis

- Compliance with diary

- Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

- Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
tube

- Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder
at the time of Screening (Visit 1)

- Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

- History of gastrointestinal disorders that may be similar to gastroparesis

- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Gastroparesis

Intervention(s)

Drug: Relamorelin

Drug: Placebo

Primary Outcome(s)

To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment [Time Frame: Baseline to Week 12]

Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Percentage of Patients Meeting the Abdominal Pain Responder Criterion [Time Frame: Baseline to Week 12]

Percentage of Patients Meeting the Bloating Responder Criterion [Time Frame: Baseline to Week 12]

Percentage of Patients Meeting the Postprandial Fullness Responder Criterion [Time Frame: Baseline to Week 12]

Percentage of Patients Meeting the Nausea Responder Criterion [Time Frame: Baseline to Week 12]

Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) [Time Frame: Baseline to Week 12]

Secondary ID(s)

2017-002177-20

RLM-MD-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors