Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome

NCT04985669 | Unknown Phase 4 FDA Drug

• 1 other identifier: 3420
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a semi-experimental study on constipation predominant IBS patient. One group of patient will receive prucalopride 2mg daily and another group of patient will receive lubiprostone 8 microgram twice daily. IBS-SSS and IBS-QOL score will be recorded at baseline and at follow up at 3 week and 6 week. Effectiveness of both drug will be evaluated by comparing the baseline data with data at 3 week and 6 week(IBS-SSS and IBS-QOL).

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS score), range from 0 to 500, higher scores mean worse outcome

  Change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS score) compared to baseline

  6 weeks

Secondary Outcomes (1)

• Change in Irritable Bowel Syndrome-Quality of Life (IBS -QOL score), range from 0 to 100, higher scores mean worse outcome

  6 weeks

Study Arms (2)

prucalopride group

EXPERIMENTAL

prucalopride group will receive prucalopride 2 mg once daily

Drug: Prucalopride 2mg

Lubiprostone group

ACTIVE COMPARATOR

lubiprostone group will receive lubiprostone 8 microgram twice daily

Drug: Prucalopride 2mg

Interventions

Prucalopride 2mg DRUG

one group of patient will receive prucalopride once daily one group of patient will receive lubiprostone twice daily

Also known as: calopride

Lubiprostone group; prucalopride group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet Rome IV criteria for IBS-C
• Patients given informed written consent

You may not qualify if:

• Current treatment with laxative or SSRI
• Use of any medication indicated for treatment of IBS within preceding 2 weeks of enrollment
• Organic disorder of the large or small bowel (e.g. inflammatory bowel disease, tuberculosis, diverticular disease)
• Diagnosis of any medical condition associated with constipation except IBS-C (e.g DM, Hypothyroidism, CVD, parkinsonism)
• Clinical feature suggestive of organic disease (e.g. unexplained significant weight loss, rectal bleeding)
• Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS)
• Abnormal laboratory tests (CBC, CRP, RBS, S. Creatinine, S.TSH, ECG)
• Mechanical obstruction
• Known severe depression, psychiatric disorder.
• Pregnancy or lactation

Sponsors & Collaborators

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

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1217, Bangladesh

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Suitana Meftaul Jannat, MBBS

  Resident Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Reazuddin Danish, MBBS

CONTACT

01952076155; reazuddindanish89@gmail.com

Touhid Al Mahmud, MBBS

CONTACT

01716728664; mahmudrmc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Quasi experimental

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 2, 2021
• Study Start: August 15, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)