The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome
Status:
Recruiting
Trial end date:
2021-11-20
Target enrollment:
Participant gender:
Summary
Irritable bowel syndrome (IBS) is very common functional gastrointestinal disorder in daily
gastrointestinal practice. Its etiology is multifactorial and incompletely understood.
Different types of treatment have been trying but no single drug is effective for every
patients. After the discovery of 5HT4(5 hydroxytryptamine-4) receptor and its effect on
gastrointestinal motility, 5HT4 receptor agonist becoming a good therapeutic tool in
different functional gastrointestinal disorder. Prucalopride is a selective 5HT4 agonist and
it has proven benefit in chronic idiopathic constipation but there is not enough evidence
that it is effective in constipation predominant IBS.
Objective: To assess the efficacy of Prucalopride in constipation predominant IBS patients.
Material & method: Consecutive patients of both sexes, age more than 18 years attended the
outpatient department of Gastroenterology meeting the inclusion Criteria of IBS-C will be
initially enrolled for the study. Their clinical history, examination & initial
investigations report will be noted on the standard data sheet. Any alternative diagnosis if
proven by clinical examination or laboratory investigation will be excluded from the study.
Randomization into two groups (Prucalopride and placebo) will be performed by lottery.
Patients will be randomly assigned to receive either Prucalopride 2 mg or placebo for 6
weeks. IBS symptoms will be assessed by IBS-SSS (symptom severity score) and IBS-QOL(quality
of life) at the baseline, 2nd week and 6th week of treatment (end of treatment). Any adverse
effect due to drugs will also be monitored by base line ECG, calculation of corrected QT
interval and ECG monitoring (2 weeks and 6 weeks) during the course of treatment.
Data analysis By SPSS. IBS-SSS and IBS-QOL instrument scores will be expressed as mean ±
standard deviation. Statistical analysis will be done by paired and unpaired 't' test. P
value <0.05 will be considered statistically significant.
Ethical Consideration:
Every ethical issue will be discussed with the patient regarding the study and informed
written consent will be obtained. There will be no chance of disclosure of information that
will have been harmful to the patients or others. Permission have been taken from the
concerned departmental ethical committee as well as ethical review committee of BSMMU in
order to carry out the study.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh