Prucalopride Plus Polyethylene Glycol in Bowel Preparation for ColonoscopypPhase 4NCT02781493
Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
A Phase 4 study testing 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen in people with Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp, run by Shandong University at 1 site in China.
Trial summary
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
- What is being tested?
- 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
Who cannot join
- history of colorectal surgery
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction
- known or suspected bowel obstruction or perforation
Show all 14Show fewer
- severe chronic renal failure (creatinine clearance<30 ml/min
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- dehydration
- disturbance of electrolytes
- pregnancy or lactation
- haemodynamically unstable
- unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-0531-82169236, liyanqing@sdu.edu.cn
About this study
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Read the detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.
- Being tested
- 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen, 2 mg Placebo plus 2 L Polyethylene Glycol regimen
- Keywords
- Prucalopride, Polyethylene Glycol, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg Prucalopride plus 2 L Polyethylene Glycol regimenDrug
Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.
2 mg Placebo plus 2 L Polyethylene Glycol regimenDrug
Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride group | Experimental | 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen Receives: Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen |
| Placebo group | Placebo comparator | 2 mg Placebo plus 2 L Polyethylene Glycol regimen Receives: Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups.
Measured: 9 months
Secondary outcomes (2)
Polyp detection rate between 2 groups.
Measured: 9 months
rate of adverse events between 2 groups.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prucalopride Plus Polyethylene Glycol in Bowel Preparation for ColonoscopypStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Binzhou People's Hospital, Tai'an People's Hospital, Linyi People's Hospital
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781493
- Sponsor's protocol ID
- 2016SDU-QILU-06
- Status last verified
- May 2016
- First submitted
- 21 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT02781493
- Acronym / sponsor ID
- 2016SDU-QILU-06
- Keywords
- Prucalopride, Polyethylene Glycol, bowel preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Binzhou People's Hospital, Tai'an People's Hospital, Linyi People's Hospital
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 24 May 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.
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prucalopride group | Experimental | Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen2 mg Prucalopride plus 2 L Polyethylene Glycol regimen |
| Placebo group | Placebo comparator | Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen2 mg Placebo plus 2 L Polyethylene Glycol regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
Key exclusion criteria (14 listed)
- history of colorectal surgery
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction
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 |
|---|---|---|
| 2 mg Prucalopride plus 2 L Polyethylene Glycol regimenPatients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy. | Drug | Prucalopride group |
| 2 mg Placebo plus 2 L Polyethylene Glycol regimenPatients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy. | Drug | Placebo group |
Primary outcome
Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
Time frame: 9 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups.
2 secondary outcomes
Polyp detection rate between 2 groups.
Time frame: 9 months
rate of adverse events between 2 groups.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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.
Li Yanqing, MD, PhD principal investigator
Qilu Hospital of Shandong University
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 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen in people with Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp, run by Shandong University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 27 May 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 China. 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 Li Yanqing, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of scores rating by Boston Bowel Preparation Scale between 2 groups. (time frame: 9 months). 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 27 May 2016.