Study of Metoclopramide in Small Bowel Capsule Endoscopy

NCT ID: NCT01630109

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-06-30

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.

Conditions

Pill Capsule Endoscopy Completion Rates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Metoclopramide 5 mg

Pro-motility agent

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.

Metoclopramide 10 mg

Pro-motility agent

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.

Placebo control

Placebo to be used as the control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo capsule made to look like the metoclopramide capsule.

Interventions

Metoclopramide

A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.

Intervention Type: DRUG

Placebo

A placebo capsule made to look like the metoclopramide capsule.

Intervention Type: DRUG

Other Intervention Names

Brand name of Metoclopramide is Reglan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascension Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Steven Brooks

DO/Internal Medicine Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven D Brooks, D.O.

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Countries

United States

Other Identifiers

GRMC120006

Identifier Type: -

Identifier Source: org_study_id