The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome

NCT04757493 | Unknown Phase 2 DMC

• 1 other identifier: BSMMU/2021/394
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Assess the Change of IBS symptoms from baseline by using IBS-Symptom Severity Score

  IBS-Symptom Severity Score is a 5 item tools.This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-Symptom Severity Score calculates the sum of these 5 items scored on a visual analogue scale from 0-100. Determination of severity of each symptom is determined by the patient.The items are summed and thus the total score can range from 0 to 500 points. IBS severity has the following defined ranges: mild 75-174, moderate 175-300, and severe \> 300. Improvement is defined as decrease of 50 points from baseline.

  Base line, during treatment (2nd week) and after 6 weeks

• Assess the change of quality of life from baseline by using IBS- Quality of life questionnaire

  IBS-Quality of life instrument contains 34 question items relating to symptoms of IBS. The magnitude of the respondents feelings to each item is determined by the patients selection of the five Likert-style responses.Responses are transformed to reverse code system. The total score is transformed to 0-100 scale where 0 means poor quality of life and 100 means maximum quality of life. Ten(10) points improvement from base line will be considered clinically meaningful improvement

  Base line, during treatment (2nd week) and after 6 weeks

Study Arms (2)

Prucalopride group (A)

ACTIVE COMPARATOR

Prucalopride 2 mg tablet, once daily in morning before breakfast will use as intervention in arm "A".

Drug: Prucalopride 2mg

Placebo group (B)

PLACEBO COMPARATOR

Placebo will be given at the same time and same dose in arm "B" . Both active drug and placebo have packed in the same type of strip.

Drug: Prucalopride 2mg

Interventions

Prucalopride 2mg DRUG

Both prucalopride 2mg and placebo will be administered for 6 weeks. Primary outcome will measure at 2nd and 6th week of treatment.

Also known as: Placebo

Placebo group (B); Prucalopride group (A)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-65 years.
• Patients who will Meet Rome IV criteria for IBS-Constipation (IBS-C).
• Patients classified as IBS-C had \> 25% hard or lumpy stool (Bristol stool scale 1-2) and \< 25% loose or watery (Bristol stool scale 6-7).
• Absence of alarm features (rectal bleeding, anemia, unexplained weight loss, and a family history of organic GI diseases (e.g. colon cancer or inflammatory bowel disease).
• Patients more than 55 years when full colonoscopy will normal.
• Patients given informed written consent.

You may not qualify if:

• Current treatment with laxative and Selective Serotonin Re-uptake Inhibitor.
• Unable or Unwilling to stop medication including lactulose, lubiprostone etc.
• Known organic bowel diseases (e.g. inflammatory bowel disease, tuberculosis, diverticular disease, etc.).
• Secondary causes of constipation e.g. Diabetes Mellitus, Hypothyroidism, Cerebrovascular disease and Parkinsonism. Known severe depression and psychiatric disorder.
• Clinical feature suggestive of organic disease (H/O weight loss, per rectal bleeding, family history of malignancy etc).
• Previous GI surgery.
• Pregnancy or lactation.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Shahbag

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prof.Dr. Anwarul Kabir, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY DIRECTOR

Central Study Contacts

Ovizit Saha, MBBS

CONTACT

+8801717624559; ovizitsaharmc47@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider and primary outcome assessor will unaware about the allocated treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident, Gastroenterology

Model Details: Its a randomized placebo controlled parallel group clinical trial. Prucalopride group is designated as "A" and placebo group is designated as group "B".

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: March 10, 2021
• Primary Completion: October 20, 2021
• Study Completion: November 20, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)