A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Inclusion Criteria:
Two different groups of participants may enter into the study:
Rollover Participants
Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
De Novo Participants
Exclusion Criteria:
Both Rollover and De Novo Participants
•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
Rollover Participants
•Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
De Novo Participants
Chevy Chase, Maryland 20815, United States
Frederick, Maryland 21701, United States
Wyoming, Michigan 49519, United States
Buenos Aires, Buenos Aires C1425AGC, Argentina
CABA, Buenos Aires C1419AHN, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Adelaide, South Australia 5000, Australia
Joinville, Santa Catarina 89201-260, Brazil
Barranquilla, Atlántico 080020, Colombia
Bogotá, Cundinamarca 111311, Colombia
Pereira, Risaralda Department 660003, Colombia
Szeged, H-6720, Hungary
Hyderabad, Andhra Pradesh 500072, India
Ahmedabad, Gujarat 380007, India
Bengaluru, Karnataka 560002, India
Kubang Kerian, 16150, Malaysia
Mexico City, Mexico City 11650, Mexico
Durango, 34270, Mexico
St-Petersburg, Leningradskaya Oblast' 199106, Russia
Dnipro, Dnipropetrovsk Oblast 49027, Ukraine
Zaporizhzhya, Zaporizhzhia Oblast 69600, Ukraine
Chernivtsi, 58022, Ukraine
Kharkiv, 61070, Ukraine
Kyiv, 3049, Ukraine
Kyiv, 4050, Ukraine
Odesa, 65010, Ukraine
Zaporizhzhya, 69035, Ukraine