Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
1 other identifier
interventional
600
1 country
1
Brief Summary
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 27, 2016
May 1, 2016
9 months
May 21, 2016
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9 months
Secondary Outcomes (2)
Polyp detection rate between 2 groups.
9 months
rate of adverse events between 2 groups.
9 months
Study Arms (2)
Prucalopride group
EXPERIMENTAL2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
Placebo group
PLACEBO COMPARATOR2 mg Placebo plus 2 L Polyethylene Glycol regimen
Interventions
Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.
Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.
Eligibility Criteria
You may qualify if:
- Patients 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- Binzhou People's Hospitalcollaborator
- Tai'an People's Hospitalcollaborator
- Linyi People's Hospitalcollaborator
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Li Yanqing, MD, PhD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
May 21, 2016
First Posted
May 24, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
May 27, 2016
Record last verified: 2016-05