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A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis

Gastroparesis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of 12 Weeks of Once-daily Dosing of the Oral Motilin Receptor Agonist Camicinal, on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02210000
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date August 27, 2014
Completion date August 24, 2015
View Details
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