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

A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Transit Time
• Intervention / Treatment: Drug: metoclopramide

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Dissolving metoclopramide; Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.	Drug: metoclopramide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Transit Time	Time for transit through small intestine.	Day 1

Collaborators and Investigators

• Sponsor: Winthrop University Hospital
• Investigators: Principal Investigator: David Friedel, MD, Winthrop University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: metoclopramide video capsule endoscopy gastric transit time
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: WUH 254286-5