Pill Capsule Endoscopy Completion RatesPhase 4NCT01630109

Study of Metoclopramide in Small Bowel Capsule Endoscopy

A Phase 4 study testing Metoclopramide in people with Pill Capsule Endoscopy Completion Rates, run by Ascension Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pill Capsule Endoscopy Completion Rates
What is being tested?: Metoclopramide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Jun 2013
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.

Who cannot join

Inability to sign consent for research participation
Inability to swallow PillCam™, placebo, or metoclopramide capsule
Known hypersensitivity/allergy to metoclopramide
Active congestive heart failure or respiratory failure requiring ventilator assistance
Presence of cardiac pacemaker or implanted electromedical device
Known bowel obstruction/stricture/fistula or intrauterine pregnancy

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Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of capsule retention in a blind intestinal limb necessitating surgical retrieval
Known history of seizure disorder, renal failure requiring dialysis, or pheochromocytoma
Lactating women

Trial locations and contacts

1 site in 1 country.

United States1 site

Genesys Regional Medical Center
Grand Blanc, Michigan, 48439

Other trials in United States

About this study

Official title: Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times

Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.

Read the detailed description

Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.

Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.

Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.

Conditions: Pill Capsule Endoscopy Completion Rates
Being tested: Metoclopramide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetoclopramideDrug
Also called Brand name of Metoclopramide is Reglan
A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.
PlaceboDrug
A placebo capsule made to look like the metoclopramide capsule.

Study groups in NCT01630109
Study group	Role	What they receive
Metoclopramide 5 mg	Active comparator	Pro-motility agent Receives: Drug: Metoclopramide
Metoclopramide 10 mg	Active comparator	Pro-motility agent Receives: Drug: Metoclopramide
Placebo control	Placebo comparator	Placebo to be used as the control group Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Treatment vs. Placebo in Pill Capsule Completion Rates
This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).
Measured: 12 hours

Secondary outcomes (3)

Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies
This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.
Measured: 12 hours
Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies
This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.
Measured: 12 hours
Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics
This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Jun 2013

First posted28 Jun 2012 (estimated)
Study startDec 2012
Primary completionJun 2013
Study completionJun 2013

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 Pill Capsule Endoscopy Completion RatesStudies 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 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01630109
Sponsor's protocol ID: GRMC120006
Status last verified: Jan 2014
First submitted: 26 Jun 2012
Last updated: 27 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times
ClinicalTrials.gov ID: NCT01630109
Acronym / sponsor ID: GRMC120006
Conditions: Pill Capsule Endoscopy Completion Rates
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Ascension HealthIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 28 Jun 2012 (estimated)
Results: Posted 27 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Metoclopramide 5 mg	Active comparator	Drug: MetoclopramidePro-motility agent
Metoclopramide 10 mg	Active comparator	Drug: MetoclopramidePro-motility agent
Placebo control	Placebo comparator	Drug: PlaceboPlacebo to be used as the control group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.

Key exclusion criteria (9 listed)

Inability to sign consent for research participation
Inability to swallow PillCam™, placebo, or metoclopramide capsule
Known hypersensitivity/allergy to metoclopramide
Active congestive heart failure or respiratory failure requiring ventilator assistance
Presence of cardiac pacemaker or implanted electromedical device

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
MetoclopramideAlso: Brand name of Metoclopramide is ReglanA one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.	Drug	Metoclopramide 10 mg, Metoclopramide 5 mg
PlaceboA placebo capsule made to look like the metoclopramide capsule.	Drug	Placebo control

Primary outcome

Difference in Treatment vs. Placebo in Pill Capsule Completion Rates
Time frame: 12 hours
This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).

3 secondary outcomes

Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies
Time frame: 12 hours
Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies
Time frame: 12 hours
Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics
Time frame: 12 hours

Results and safety

Results posted to the registry on 27 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metoclopramide 5 mg	1	1
Metoclopramide 10 mg	1	1
Placebo Control	3	3

Primary outcome: Difference in Treatment vs. Placebo in Pill Capsule Completion Rates

Time frame: 12 hours. Number. Unit: percentage of complete capsule studies

Measure	Metoclopramide 5 mg n = 1	Metoclopramide 10 mg n = 1	Placebo Control n = 3
Value	100	0	100

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metoclopramide 5 mg	0 of 1 (0%)	0 of 1 (0%)	Not reported
Metoclopramide 10 mg	0 of 1 (0%)	0 of 1 (0%)	Not reported
Placebo Control	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): The main limitation of this study was that there was a lower number of capsule studies performed at the study center than anticipated so it was difficult to find patients to enroll.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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.

Steven D Brooks, D.O. principal investigator

Ascension Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metoclopramide in people with Pill Capsule Endoscopy Completion Rates, run by Ascension Health 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 27 Feb 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2014). 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?

Difference in Treatment vs. Placebo in Pill Capsule Completion Rates (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01630109.

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 27 Feb 2014.