Study of Metoclopramide in Small Bowel Capsule Endoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Brooks, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01630109
First received: June 26, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pill Capsule Endoscopy Completion Rates
Drug: Metoclopramide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Difference in Treatment vs. Placebo in Pill Capsule Completion Rates [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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:
  • Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.

  • Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.

  • Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630109

Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Steven D Brooks, D.O. Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: Steven Brooks, DO/Internal Medicine Resident, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01630109     History of Changes
Other Study ID Numbers: GRMC120006
Study First Received: June 26, 2012
Results First Received: August 23, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014