Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
David Friedel, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01631994
First received: June 24, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

Summary:

This study investigates the use of oral dissolving metoclopramide during standard video capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps with movement through the stomach and small bowel. This study will help us determine the effectiveness of oral dissolving metoclopramide on transit time through the stomach and small bowel of the video capsule that is ingested. This study may help with better diagnoses of pathology in the small bowel. Each patient enrolled in the study will either be assigned to a group that only ingests the capsule or the group that receives the oral dissolving metoclopramide plus capsule. Each patient will undergo the same standard procedures and precaution used during standard video capsule endoscopy. The patients that will qualify for the study are patients that are in need of video capsule endoscopy for further imaging of the small bowel. The patients must meet the inclusion criteria provided in the protocol and must not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients that ingest the metoclopramide will have better capsule images and transit time and will allow for enhanced diagnosis of small bowel pathology.


Condition Intervention
Gastric Transit Time
Drug: metoclopramide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Title: A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Gastric Transit Time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Dissolving metoclopramide
Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
Drug: metoclopramide
1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
No Intervention: control group
This is the control group that will only ingest the capsule during video capsule endoscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients 18 years - 70 years old, male or female, belonging to any race or ethnic origin.
  2. Patients necessitating video capsule endoscopy.
  3. Patients who are willing and competent to sign an informed consent and to comply with study related visits and procedures.

Exclusion Criteria:

  1. Patients below the age of 18 or greater than 70 years old.
  2. Pregnant patients
  3. Patients with a documented history of Parkinson's Disease or Parkinsonian Symptoms, Tardive Dyskinesia, history of neuroleptic malignant syndrome, history or seizure disorder.
  4. Patients who are currently taking antipsychotic medications including typical and atypical antipsychotics.
  5. Patients taking other drugs that may cause extrapyramidal reactions.
  6. Patients with a history of cirrhosis or congestive heart failure.
  7. Patients with a history of depression.
  8. Patients with uncontrolled hypertension.
  9. Patients with renal impairment, creatinine clearance < 40ml/minute.
  10. Patients who have massive gastrointestinal hemorrhage, mechanical obstruction, or perforation.
  11. Patients with a known history of pheochromocytoma, as this may precipitate hypertensive crisis.
  12. Patients with a known sensitivity or intolerance to metoclopramide.
  13. Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study.
  14. Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest.
  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: NCT01631994

Contacts
Contact: David Friedel, MD 516 663 2066 dfriedel@winthrop.org
Contact: Elizabeth Williams, DO 516 663 2066 williamselizabet@gmail.com

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: David Friedel, MD    516-663-2066    dfriedel@winthrop.org   
Contact: Elizabeth Williams, DO    516 663 2066    williamselizabet@gmail.com   
Principal Investigator: David Friedel, MD         
Sub-Investigator: Vineet Korrapati, MD         
Sub-Investigator: Elizabeth Williams, DO         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: David Friedel, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: David Friedel, Associate Professor of Clinical Medicine, School of Medicine, State University of New York at Stony Brook, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01631994     History of Changes
Other Study ID Numbers: 254286-5
Study First Received: June 24, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
metoclopramide video capsule endoscopy gastric transit time

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 August 28, 2014