Study of Metoclopramide in Small Bowel Capsule Endoscopy

Phase 4

Completed

Conditions: Pill Capsule Endoscopy Completion Rates

Interventions: Drug: Placebo
Drug: Metoclopramide

Registration Number: NCT01630109

Lead Sponsor: Ascension Health

Brief 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.

Detailed Description: Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.

Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.

Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control	Placebo	Placebo to be used as the control group
Metoclopramide 5 mg	Metoclopramide	Pro-motility agent
Metoclopramide 10 mg	Metoclopramide	Pro-motility agent

Primary Outcome Measures

Name	Time	Method
Difference in Treatment vs. Placebo in Pill Capsule Completion Rates	12 hours	This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).

Secondary Outcome Measures

Name	Time	Method
Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies	12 hours	This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.
Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics	12 hours	This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.
Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies	12 hours	This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.