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

NCT01631994 | Terminated Results DMC

• 1 other identifier: WUH 254286-5
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Transit Time

Keywords

metoclopramide video capsule endoscopy gastric transit time

Outcome Measures

Primary Outcomes (1)

• Gastric Transit Time

  Time for transit through small intestine.

  Day 1

Study Arms (2)

Oral Dissolving metoclopramide

EXPERIMENTAL

Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.

Drug: metoclopramide

control group

NO INTERVENTION

This is the control group that will only ingest the capsule during video capsule endoscopy.

Interventions

metoclopramide DRUG

1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.

Oral Dissolving metoclopramide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Interventions

Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Results Point of Contact

• Title: David Friedel, MD
• Organization: NYU Winthrop Hospital, Dep't of Gastroenterology

DFriedel@nyuwinthrop.org

(516) 663-2528

Study Officials

• David Friedel, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: June 29, 2012
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-03

Locations

US (1)