Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01631994
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
David Friedel, Winthrop University Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date January 12, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Gastric Transit Time [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
Official Title  ICMJE Title: A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Gastric Transit Time
Intervention  ICMJE Drug: metoclopramide
1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
Study Arms  ICMJE
  • Experimental: Oral Dissolving metoclopramide
    Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
    Intervention: Drug: metoclopramide
  • No Intervention: control group
    This is the control group that will only ingest the capsule during video capsule endoscopy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
4
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
170
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631994
Other Study ID Numbers  ICMJE 254286-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Friedel, Winthrop University Hospital
Study Sponsor  ICMJE Winthrop University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Friedel, MD Winthrop University Hospital
PRS Account Winthrop University Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP