Prucalopride Versus Placebo in Gastroparesis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second regimen in cross-over.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• Consecutive patients with a previously established diagnosis of diabetes or functional dyspepsia according to Rome III criteria, and with delayed gastric emptying (t1/2 for solids ≥ 109 min) on a breath test

Exclusion Criteria:

• The presence of oesophagitis, gastric atrophy or erosive gastroduodenal lesions on endoscopy

• the presence of lesions on small bowel X-ray

• major abdominal surgery

• underlying psychiatric illness

• use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric motility.

• Major co-morbidities