Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
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.
|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.|
- Gastric Transit Time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2014 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631994
|Contact: David Friedel, MD||516 663 email@example.com|
|Contact: Elizabeth Williams, DO||516 663 firstname.lastname@example.org|
|United States, New York|
|Winthrop University Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Contact: David Friedel, MD 516-663-2066 email@example.com|
|Contact: Elizabeth Williams, DO 516 663 2066 firstname.lastname@example.org|
|Principal Investigator: David Friedel, MD|
|Sub-Investigator: Vineet Korrapati, MD|
|Sub-Investigator: Elizabeth Williams, DO|
|Principal Investigator:||David Friedel, MD||Winthrop University Hospital|