Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02781493
• Other study ID #: 2016SDU-QILU-06
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 21, 2016
• Last updated: May 25, 2016
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2016
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients 18 years of age or older,

• scheduled to undergo elective outpatient colonoscopy,

• and were able to provide informed consent.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp

Intervention

Drug:
• 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
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 regimen
Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Binzhou People's Hospital, Linyi People's Hospital, Tai'an People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Polyp detection rate between 2 groups.		9 months	No
Secondary	rate of adverse events between 2 groups.		9 months	No