A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
Status:
Completed
Trial end date:
2015-08-24
Target enrollment:
Participant gender:
Summary
This study is a randomized, double-blind, placebo controlled trial designed to confirm the
symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1
and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine
if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves
gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily
Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who
have documented abnormally slow gastric emptying and have symptoms consistent with
gastroparesis.
Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study
will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a
2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety
follow-up visit.