Study of Metoclopramide in Small Bowel Capsule Endoscopy

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.

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

Details

• Lead Sponsor: Ascension Genesys Hospital; Genesys Regional Medical Center
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

• Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.

Exclusion Criteria:

• Inability to sign consent for research participation

• Inability to swallow PillCam™, placebo, or metoclopramide capsule

• Known hypersensitivity/allergy to metoclopramide

• Active congestive heart failure or respiratory failure requiring ventilator assistance

• Presence of cardiac pacemaker or implanted electromedical device

• Known bowel obstruction/stricture/fistula or intrauterine pregnancy

• Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of capsule retention in a blind intestinal limb necessitating surgical retrieval

• Known history of seizure disorder, renal failure requiring dialysis, or pheochromocytoma

• Lactating women