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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631994
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
David Friedel, Winthrop University Hospital

Brief 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 or disease Intervention/treatment Phase
Gastric Transit Time Drug: metoclopramide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : September 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Gastric Transit Time [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01631994

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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
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Principal Investigator: David Friedel, MD Winthrop University Hospital
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Responsible Party: David Friedel, Associate Professor of Clinical Medicine, School of Medicine, State University of New York at Stony Brook, Winthrop University Hospital Identifier: NCT01631994    
Other Study ID Numbers: 254286-5
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by David Friedel, Winthrop University Hospital:
metoclopramide video capsule endoscopy gastric transit time
Additional relevant MeSH terms:
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Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action