Clinical trial NCT01631994: Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
Official title: A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastric Transit Time
Keywords: metoclopramide video capsule endoscopy gastric transit time
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Gastric Transit Time
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: David Friedel, MD
role: PRINCIPAL_INVESTIGATOR
References: