Study of Metoclopramide in Small Bowel Capsule Endoscopy

Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times

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.

Study Overview

• Status: Completed
• Conditions: Pill Capsule Endoscopy Completion Rates
• Intervention / Treatment: Drug: Metoclopramide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metoclopramide 5 mg; Pro-motility agent	Drug: Metoclopramide; A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.; Other Names: Brand name of Metoclopramide is Reglan
Active Comparator: Metoclopramide 10 mg; Pro-motility agent	Drug: Metoclopramide; A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.; Other Names: Brand name of Metoclopramide is Reglan
Placebo Comparator: Placebo control; Placebo to be used as the control group	Drug: Placebo; A placebo capsule made to look like the metoclopramide capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Treatment vs. Placebo in Pill Capsule Completion Rates	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).	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies	This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.	12 hours
Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies	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.	12 hours
Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics	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.	12 hours

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital
• Investigators: Principal Investigator: Steven D Brooks, D.O., Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: GRMC120006