Study of Metoclopramide in Small Bowel Capsule Endoscopy

NCT01630109 | Completed Phase 4 Results

• 1 other identifier: GRMC120006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pill Capsule Endoscopy Completion Rates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies

  12 hours

• Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies

  12 hours

• Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics

  12 hours

Study Arms (3)

Metoclopramide 5 mg

ACTIVE COMPARATOR

Pro-motility agent

Drug: Metoclopramide

Metoclopramide 10 mg

ACTIVE COMPARATOR

Pro-motility agent

Drug: Metoclopramide

Placebo control

PLACEBO COMPARATOR

Placebo to be used as the control group

Drug: Placebo

Interventions

Metoclopramide DRUG

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

Also known as: Brand name of Metoclopramide is Reglan

Metoclopramide 10 mg; Metoclopramide 5 mg

Placebo DRUG

A placebo capsule made to look like the metoclopramide capsule.

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascension Health: lead

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Interventions

Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Limitations and Caveats

The main limitation of this study was that there was a lower number of capsule studies performed at the study center than anticipated so it was difficult to find patients to enroll.

Results Point of Contact

• Title: Dr. Steven Brooks
• Organization: Genesys Regional Medical Center Office of Research

Steven.Brooks@genesys.org

8106067722

Study Officials

• Steven D Brooks, D.O.

  Ascension Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO/Internal Medicine Resident

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 27, 2014
• Results First Posted: February 27, 2014

Record last verified: 2014-01

Locations

US (1)