Purpose: the purpose of the study is to evaluate the safety and efficacy of Relamorelin in Patients with Diabetic Gastroparesis.
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Study Sponsor: Allergan Sales, LLC
- Males and females aged 18 and older with BMI >18.5kg/m
- Type 1 or Type 2 Diabetes for at least 5 years duration, with controlled and stable blood glucose levels and HbA1c ≤11.0% at screening (visit 1)
- Symptoms suggestive of Diabetic Gastroparesis (DG) for at least 3 months, (e.g…Nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety), with mechanical obstruction of the gastrointestinal (GI) tract as the cause of symptoms having been ruled out.
- History of at least 4 vomiting episodes in the past month.
Study description: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis.