Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome
Primary Purpose
Patient Satisfaction
Status
Unknown status
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Prucalopride 2mg
Sponsored by
About this trial
This is an interventional other trial for Patient Satisfaction
Eligibility Criteria
Inclusion criteria:
- Meet Rome IV criteria for IBS-C
- Patients given informed written consent
Exclusion Criteria:
- 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
Sites / Locations
- Bangabandhu Sheikh Mujib Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
prucalopride group
Lubiprostone group
Arm Description
prucalopride group will receive prucalopride 2 mg once daily
lubiprostone group will receive lubiprostone 8 microgram twice daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Irritable Bowel Syndrome-Quality of Life (IBS -QOL score), range from 0 to 100, higher scores mean worse outcome
Change in Irritable Bowel Syndrome-Quality of Life (IBS -QOL score) compared to baseline
Full Information
NCT ID
NCT04985669
First Posted
July 12, 2021
Last Updated
August 25, 2021
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT04985669
Brief Title
Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome
Official Title
Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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).
Detailed Description
Consecutive patients of both sexes age between 18-50 years attended the outpatient department of Gastroenterology, BSMMU, meeting the inclusion Criteria entered a 2 week screening period. During this period, patients were required to discontinue all laxative medications. All participants will be advised to maintain a stable diet with no significant changes in their consumption of liquids or fiber or in their level of physical activity.
During the screening period, patients accessed and diary system on a daily basis to report the occurrence and time of all spontaneous bowel movements (SBMs), defined as those that occurred without the use of rescue medications. If the patient did not experience a SBM for 3 or more consecutive days and needed relief, the study investigator could authorize the patient to administer a rescue medication. Initial rescue treatment consisted of a 10 mg bisacodyl. If this was not successful a Fleet enema could then be used. If both of these treatment options were unsuccessful, an alternative medication could be prescribed after consultation with the investigator. At the end of the screening period, patients were assessed by medical history, physical examination, and laboratory tests (CBC, ESR, CRP, RBS, S. creatinine, S.TSH and ECG) will be done. ECG will be done from cardiology OPD, BSMMU, and rest of the investigations from Department of Laboratory Medicine, BSMMU. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study
The subject will be recruited according to sample size. Selection into two groups will be performed non probability sampling method. An independent treatment codes and allocation will be maintained. Patients enrolled in trial were selected to receive either or prucalopride 2 mg once daily at morning before breakfast or lubiprostone 8 mcg twice daily after meal. Before starting treatment each individual will undergo a baseline assessment during which demographic data, IBS symptoms and QOL data will be recorded. Each drug was administered after with at least 8 ounces of water for a period of 6 weeks. A reduction to once-daily dosing was allowed, at the discretion of the investigator, if the patient experienced nausea or diarrhea for more than 2 days or if patients experienced other adverse events. During treatment, patients were prohibited from taking prescription or OTC medications for constipation.
Non constipation-related prescriptions and other OTC medications were allowed and their usage was documented as was as any medication change. As in the screening period, the use of rescue medications was allowed in those who failed to have a spontaneous bowel movement for 3 or more consecutive days and thus needed relief. During the 6-week study phase, clinic visits were conducted at weeks 3 and 6 week and phone interviews were performed at 1 week after starting and 2 week after the end at study period. At each clinic visit, the daily diary information was reviewed and discussed with the patient, adverse events were recorded, remaining capsules were collected to assess compliance and assessments of vital signs and laboratory parameters were performed. Patients also completed the IBS-QOL and IBS-SSS at week 3 and 6 visits. Patients will be asked to return with the strips of the ingested drugs at the end of the treatment to count & ensure compliance. Any adverse effect due to drugs will also be noted at the same time.
IBS-SSS is a 5 item tools. It is primarily a measure of IBS symptoms including abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100. Determination of severity of each symptoms is determined by patient. The nature of the items on IBS-SSS is appropriate to be used in clinical trials. 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
The IBS-QOL questionnaire is a 34-item instruments which assess QOL impairment due to IBS symptoms. Each item is scored on a five-point scale (1 = not at all, 5 = a great deal) that represents one of eight dimensions (dysphoria, interference with activity, body image, health-related worries, food avoidance, social reactions, sexual dysfunction, and relationships). Items are scored to derive an overall total score of IBS related QOL. To facilitate score interpretation, the summed total score is transformed to a 0-100 scale ranging from zero (poor QOL) to 100 (maximum QOL). The QOL instrument will be given to each patient before treatment is started; the patient will complete the form according to schedule and all data will be recorded and entered onto a data sheet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Quasi experimental
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prucalopride group
Arm Type
Experimental
Arm Description
prucalopride group will receive prucalopride 2 mg once daily
Arm Title
Lubiprostone group
Arm Type
Active Comparator
Arm Description
lubiprostone group will receive lubiprostone 8 microgram twice daily
Intervention Type
Drug
Intervention Name(s)
Prucalopride 2mg
Other Intervention Name(s)
calopride
Intervention Description
one group of patient will receive prucalopride once daily one group of patient will receive lubiprostone twice daily
Primary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS score), range from 0 to 500, higher scores mean worse outcome
Description
Change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS score) compared to baseline
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome-Quality of Life (IBS -QOL score), range from 0 to 100, higher scores mean worse outcome
Description
Change in Irritable Bowel Syndrome-Quality of Life (IBS -QOL score) compared to baseline
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Meet Rome IV criteria for IBS-C
Patients given informed written consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Md. Reazuddin Danish, MBBS
Phone
01952076155
Email
reazuddindanish89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Touhid Al Mahmud, MBBS
Phone
01716728664
Email
mahmudrmc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suitana Meftaul Jannat, MBBS
Organizational Affiliation
Resident Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1217
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DR. Shisir Shikto Sarker, MBBS
Phone
01741737376
Email
shisirsikto007@gmail.com
First Name & Middle Initial & Last Name & Degree
Tanusree Bhowmik, MBBS
Phone
01789616096
Email
tanusreedf3@gmail.com
First Name & Middle Initial & Last Name & Degree
Sandip Kumar Bhowmick, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome
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