Gastrointestinal HemorrhagePhase 4NCT02806206
Prucalopride Prior to Small Bowel Capsule Endoscopy
A Phase 4 study testing Prucalopride in people with Gastrointestinal Hemorrhage and Crohn Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Crohn Disease, Celiac Disease
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Appropriate indication for small bowel capsule endoscopy.
- Age 19 or older.
Who cannot join
- Previous partial or complete gastric resection.
- Previous small bowel surgery in which a small bowel resection has been performed or the normal anatomy has been altered.
- Presence of ileostomy.
- The requirement for endoscopic placement of the capsule endoscopy pill because of dysphagia or gastroparesis.
- Severe renal impairment, defined by the requirement for dialysis.
- Pregnancy or breast feeding.
Show all 11Show fewer
- Clinical or radiological suspicion of small bowel obstruction.
- Simultaneous use of a prokinetic agent within 5 days of the capsule endoscopy examination.
- Clinical hypo- or hyperthyroidism.
- Known hypersensitivity to the study drug.
- Unwillingness to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial
Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests.
Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel.
The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.
Read the detailed description
Capsule Endoscopy is now the first test to investigate for small bowel disease. Clinical conditions in which capsule endoscopy can be useful include gastrointestinal bleeding of unclear source, Crohn's disease, celiac disease and suspected small bowel tumors. Optimal diagnostic yield of the capsule endoscopy depends not only on adequate small bowel visualization, but also on the completion of small bowel examination. In approximately 15-20% of capsule studies, the capsule fails to pass through the small bowel into the colon because of the limited battery time which is about 8 hours. This means that a lesion or an abnormality can be missed in the portion of the small bowel that was not reached by the capsule. As a result, the capsule endoscopy test may often need to be repeated.
Multiple factors have been associated with the prolongation of the time required for the capsule to pass through the small bowel including hospitalization, prior small bowel surgery, diabetes and advanced age in addition to the prolongation of the time required for the capsule to pass through the stomach. Interventions to shorten small bowel transit time are required to increase capsule small bowel completion rates. At present there is no drug approved to shorten the small bowel transit time.
Prucalopride is a drug that has been approved for use in patients with chronic constipation. Prucalopride works on special receptors in the gut and stimulate the gut movement. There are basic and clinical studies suggesting that prucalopride may accelerate the movement of the stomach and the small bowel. Therefore, prucalopride may accelerate the passage of the capsule through the small bowel and increase the capsule completion rates. The investigators of this trial recently presented their experience of prucalopride use prior to capsule endoscopy at a medical meeting. Compared to a retrospective control group who did not receive prucalopride, prucalopride accelerated the passage of the capsule through the small bowel. There was no decrease in the diagnostic yield in the group who received prucalopride.
In this clinical trial, the investigators aim to investigate the effect of prucalopride on the small bowel transit time, by performing a randomized placebo controlled trial. Patients undergoing small bowel capsule endoscopy tests will be randomized to a single dose of prucalopride ingested at the time of capsule endoscopy ingestion, or a placebo pill. The primary objective of this study is to examine if the administration of a single dose of prucalopride shortens small bowel transit time compared to placebo. The secondary objectives include examining the effect of prucalopride on gastric transit time, small bowel capsule endoscopy completion rate and the capsule diagnostic yield. The placebo group is used in this clinical trial because there is no drug proven to be effective to shorten the small bowel transit time.
Based on the experience of the investigators, the average small bowel transit time for patients who were given prucalopride was 143 minutes. In the retrospective control group, the small bowel transit time was 229 minutes with a standard deviation of 90 minutes. Based on a presumed 20% minimal clinically important difference in small bowel transit time, the investigators determined a total of 122 participants will be required, equally divided between the two study arms.
- Conditions
- Gastrointestinal Hemorrhage, Crohn Disease, Celiac Disease, Intestinal Diseases, Inflammatory Bowel Diseases
- Being tested
- Prucalopride, Placebo
- Medical subject headings
- Gastrointestinal Hemorrhage, Crohn Disease, Celiac Disease, Intestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Restoran
A single 2 mg oral dose of prucalopride will be given to each study participant just before the ingestion of the capsule endoscopy pill.
PlaceboDrug
Also called Sugar pill
A single dose of a placebo pill will be given to each study participant just before the ingestion of the capsule endoscopy pill.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Prucalopride | Experimental | A single 2 mg dose of prucalopride before ingesting the capsule endoscopy pill. Receives: Drug: Prucalopride |
| Drug: Placebo | Placebo comparator | A placebo pill just before ingesting the capsule endoscopy pill. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel transit time
The calculated time from the first duodenal image to the first cecal image. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.
Measured: 10 hours post dose
Secondary outcomes (3)
Gastric transit time
The calculated time from the first gastric image to the first duodenal image. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.
Measured: 10 hours post dose
Small bowel completion rate
The proportion of capsule studies in which the capsule reached the cecum. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.
Measured: 10 hours post dose
Diagnostic yield
The findings were considered diagnostic if the observed finding could explain the signs/symptoms of the patient and helped plan further management or were later confirmed by other modalities. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.
Measured: 10 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fergal Donnellan, MD, Principal investigator, Division of Gastroenterology, University of British ColumbiaMajid Alsahafi, MD, Study director, Division of Gastroenterology, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806206
- Sponsor's protocol ID
- H16-01345
- Status last verified
- Jul 2016
- First submitted
- 15 Jun 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02806206
- Acronym / sponsor ID
- H16-01345
- Conditions
- Gastrointestinal Hemorrhage, Crohn Disease, Celiac Disease, Intestinal Diseases, Inflammatory Bowel Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests.
Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel.
The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.
Detailed description
Capsule Endoscopy is now the first test to investigate for small bowel disease. Clinical conditions in which capsule endoscopy can be useful include gastrointestinal bleeding of unclear source, Crohn's disease, celiac disease and suspected small bowel tumors. Optimal diagnostic yield of the capsule endoscopy depends not only on adequate small bowel visualization, but also on the completion of small bowel examination. In approximately 15-20% of capsule studies, the capsule fails to pass through the small bowel into the colon because of the limited battery time which is about 8 hours. This means that a lesion or an abnormality can be missed in the portion of the small bowel that was not reached by the capsule. As a result, the capsule endoscopy test may often need to be repeated.
Multiple factors have been associated with the prolongation of the time required for the capsule to pass through the small bowel including hospitalization, prior small bowel surgery, diabetes and advanced age in addition to the prolongation of the time required for the capsule to pass through the stomach. Interventions to shorten small bowel transit time are required to increase capsule small bowel completion rates. At present there is no drug approved to shorten the small bowel transit time.
Prucalopride is a drug that has been approved for use in patients with chronic constipation. Prucalopride works on special receptors in the gut and stimulate the gut movement. There are basic and clinical studies suggesting that prucalopride may accelerate the movement of the stomach and the small bowel. Therefore, prucalopride may accelerate the passage of the capsule through the small bowel and increase the capsule completion rates. The investigators of this trial recently presented their experience of prucalopride use prior to capsule endoscopy at a medical meeting. Compared to a retrospective control group who did not receive prucalopride, prucalopride accelerated the passage of the capsule through the small bowel. There was no decrease in the diagnostic yield in the group who received prucalopride.
In this clinical trial, the investigators aim to investigate the effect of prucalopride on the small bowel transit time, by performing a randomized placebo controlled trial. Patients undergoing small bowel capsule endoscopy tests will be randomized to a single dose of prucalopride ingested at the time of capsule endoscopy ingestion, or a placebo pill. The primary objective of this study is to examine if the administration of a single dose of prucalopride shortens small bowel transit time compared to placebo. The secondary objectives include examining the effect of prucalopride on gastric transit time, small bowel capsule endoscopy completion rate and the capsule diagnostic yield. The placebo group is used in this clinical trial because there is no drug proven to be effective to shorten the small bowel transit time.
Based on the experience of the investigators, the average small bowel transit time for patients who were given prucalopride was 143 minutes. In the retrospective control group, the small bowel transit time was 229 minutes with a standard deviation of 90 minutes. Based on a presumed 20% minimal clinically important difference in small bowel transit time, the investigators determined a total of 122 participants will be required, equally divided between the two study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Prucalopride | Experimental | Drug: PrucaloprideA single 2 mg dose of prucalopride before ingesting the capsule endoscopy pill. |
| Drug: Placebo | Placebo comparator | Drug: PlaceboA placebo pill just before ingesting the capsule endoscopy pill. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Appropriate indication for small bowel capsule endoscopy.
- Age 19 or older.
Key exclusion criteria (11 listed)
- Previous partial or complete gastric resection.
- Previous small bowel surgery in which a small bowel resection has been performed or the normal anatomy has been altered.
- Presence of ileostomy.
- The requirement for endoscopic placement of the capsule endoscopy pill because of dysphagia or gastroparesis.
- Severe renal impairment, defined by the requirement for dialysis.
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 |
|---|---|---|
| PrucaloprideAlso: RestoranA single 2 mg oral dose of prucalopride will be given to each study participant just before the ingestion of the capsule endoscopy pill. | Drug | Drug: Prucalopride |
| PlaceboAlso: Sugar pillA single dose of a placebo pill will be given to each study participant just before the ingestion of the capsule endoscopy pill. | Drug | Drug: Placebo |
Primary outcome
Small bowel transit time
Time frame: 10 hours post dose
The calculated time from the first duodenal image to the first cecal image. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.
3 secondary outcomes
Gastric transit time
Time frame: 10 hours post dose
Small bowel completion rate
Time frame: 10 hours post dose
Diagnostic yield
Time frame: 10 hours post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Fergal Donnellan, MD principal investigator
Division of Gastroenterology, University of British Columbia
Majid Alsahafi, MD study director
Division of Gastroenterology, University of British Columbia
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 Prucalopride in people with Gastrointestinal Hemorrhage and Crohn Disease, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Jul 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fergal Donnellan, MD (6048755474, Fergal.Donnellan@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel transit time (time frame: 10 hours post dose). 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 15 Jul 2016.