Gastric Transit TimeNCT01631994
Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
A study testing metoclopramide in people with Gastric Transit Time, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Transit Time
- What is being tested?
- metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: 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.
- Conditions
- Gastric Transit Time
- Being tested
- metoclopramide
- Keywords
- metoclopramide video capsule endoscopy gastric transit time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramideDrug
1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
| Study group | Role | What they receive |
|---|---|---|
| Oral Dissolving metoclopramide | Experimental | Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy. Receives: Drug: metoclopramide |
| control group | No intervention | This is the control group that will only ingest the capsule during video capsule endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Transit Time
Time for transit through small intestine.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: No support to run the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric Transit TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Friedel, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631994
- Sponsor's protocol ID
- WUH 254286-5
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2012
- Last updated
- 11 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.
- ClinicalTrials.gov ID
- NCT01631994
- Acronym / sponsor ID
- WUH 254286-5
- Conditions
- Gastric Transit Time
- Keywords
- metoclopramide video capsule endoscopy gastric transit time
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No support to run the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Posted 11 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Dissolving metoclopramide | Experimental | Drug: metoclopramidePatient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy. |
| control group | No intervention | –This is the control group that will only ingest the capsule during video capsule endoscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metoclopramide1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule. | Drug | Oral Dissolving metoclopramide |
Primary outcome
Gastric Transit Time
Time frame: Day 1
Time for transit through small intestine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Friedel, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metoclopramide in people with Gastric Transit Time, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Transit Time (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.