Conditions: Gastroparesis
Keywords: repeat dose phase II GCSI-DD pharmacodynamics gastroparesis type 1 and type 2 diabetes mellitus camicinal GSK962040 symptoms gut motility
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84 arm 2: Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84

Interventions: intervention 1: Placebo intervention 2: Camicinal
Intervention descriptions: intervention 1: Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning intervention 2: Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning

Protocol document: