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



Status:Recruiting
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:February 20, 2018
End Date:January 18, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in
patients with diabetic gastroparesis. Patients will report daily severity scores of their
diabetic gastroparesis symptoms.


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

- History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the
past 5 years

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

- History of gastrointestinal disorders that may be similar to gasteroparisis

- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
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