Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
This study has been completed.
Information provided by (Responsible Party):
David Friedel, Winthrop University Hospital
First received: June 24, 2012
Last updated: January 11, 2016
Last verified: January 2016
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.
Gastric Transit Time
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
||Title: A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.
Primary Outcome Measures:
- Gastric Transit Time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
Experimental: Oral Dissolving metoclopramide
Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
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.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients 18 years - 70 years old, male or female, belonging to any race or ethnic origin.
- Patients necessitating video capsule endoscopy.
- Patients who are willing and competent to sign an informed consent and to comply with study related visits and procedures.
- Patients below the age of 18 or greater than 70 years old.
- Pregnant patients
- Patients with a documented history of Parkinson's Disease or Parkinsonian Symptoms, Tardive Dyskinesia, history of neuroleptic malignant syndrome, history or seizure disorder.
- Patients who are currently taking antipsychotic medications including typical and atypical antipsychotics.
- Patients taking other drugs that may cause extrapyramidal reactions.
- Patients with a history of cirrhosis or congestive heart failure.
- Patients with a history of depression.
- Patients with uncontrolled hypertension.
- Patients with renal impairment, creatinine clearance < 40ml/minute.
- Patients who have massive gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with a known history of pheochromocytoma, as this may precipitate hypertensive crisis.
- Patients with a known sensitivity or intolerance to metoclopramide.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631994
|Winthrop University Hospital
|Mineola, New York, United States, 11501 |
Winthrop University Hospital
||David Friedel, MD
||Winthrop University Hospital
||David Friedel, Associate Professor of Clinical Medicine, School of Medicine, State University of New York at Stony Brook, Winthrop University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 24, 2012
||January 11, 2016
||United States: Institutional Review Board
Keywords provided by Winthrop University Hospital:
metoclopramide video capsule endoscopy gastric transit time
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Peripheral Nervous System Agents
Physiological Effects of Drugs
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Molecular Mechanisms of Pharmacological Action