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

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

Tracking Information

• First Submitted Date: June 24, 2012
• First Posted Date: June 29, 2012
• Last Update Posted Date: January 12, 2016
• Study Start Date: September 2011
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 28, 2012): Gastric Transit Time [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Diagnostic
• Condition: Gastric Transit Time

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 11, 2016): 4
• Original Estimated Enrollment (submitted: June 28, 2012): 170
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01631994
• Other Study ID Numbers: 254286-5
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David Friedel, Winthrop University Hospital
• Study Sponsor: Winthrop University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Friedel, MD; Winthrop University Hospital

• PRS Account: Winthrop University Hospital
• Verification Date: January 2016