Irritable Bowel SyndromePhase 2/3NCT04757493
The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome
A Phase 2/3 study testing Prucalopride 2mg in people with Irritable Bowel Syndrome, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Prucalopride 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Mar 2021to 20 Nov 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Shahbag
Dhaka, 1000
Ovizit Saha, MBBS, +8801717060747, ovizitsaharmc47@bsmmu.edu.bd
About this study
Official title: The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome: A Double Blind Placebo Controlled Trial
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.
Read more
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.
Read the detailed description
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 with Complete Blood Count , C-Reactive Protein, Tissue Transglutaminase antibody, Oral Glucose Tolerance Test, Thyroid Stimulating Hormone will be done from respected department of 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. All participants will be advised to maintain their usual dietary practices throughout the study. The subject will be recruited according to sample size. Total study population will be divided in to Prucalopride and placebo group. An independent treatment code will be generated and allocated according to sample size in each group. Randomization into two groups will be performed by lottery. The independent treatment codes and allocation will be maintained, which will be locked until all analyses will have been completed. Thus, the clinical trial will be performed double-blind with all patients and investigators will unaware of which treatment is allocated.
One group will receive tab Prucalopride 2 mg once daily 30 minute before breakfast, while the other group will receive identical looking placebo one tab once daily at same time. The tablets will be administered for a total of 6 weeks. Before starting treatment each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS-SSS and QOL data will be recorded. Patients will be followed-up at 2 weeks, then at 6 weeks by IBS-SSS questionnaire and IBS-QOL questionnaire. 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 monitored by base line ECG, calculation of corrected QT interval and ECG monitoring (2 weeks and 6 weeks) during the course of treatment. Any adverse event will be responded quickly and documented 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 symptom is determined by the 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 = extremely) that represents one of eight dimensions (dysphoria, interference with activity, body image, health-related worries, food avoidance, social reactions, sexual dysfunction, and relationships). After scoring by the patient, responses will be transformed to reverse code system (5= not at all, 1= extremely). 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Prucalopride 2mg
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prucalopride 2mgDrug
Also called Placebo
Both prucalopride 2mg and placebo will be administered for 6 weeks. Primary outcome will measure at 2nd and 6th week of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride group (A) | Active comparator | Prucalopride 2 mg tablet, once daily in morning before breakfast will use as intervention in arm "A". Receives: 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. Receives: Drug: Prucalopride 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Base line, during treatment (2nd week) and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start10 Mar 2021
- Primary completion20 Oct 2021
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Its a randomized placebo controlled parallel group clinical trial. Prucalopride group is designated as "A" and placebo group is designated as group "B".
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ovizit Saha, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Prof.Dr. Anwarul Kabir, MD, Study director, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757493
- Sponsor's protocol ID
- BSMMU/2021/394
- Status last verified
- Oct 2021
- First submitted
- 8 Feb 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome: A Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04757493
- Acronym / sponsor ID
- BSMMU/2021/394
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 with Complete Blood Count , C-Reactive Protein, Tissue Transglutaminase antibody, Oral Glucose Tolerance Test, Thyroid Stimulating Hormone will be done from respected department of 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. All participants will be advised to maintain their usual dietary practices throughout the study. The subject will be recruited according to sample size. Total study population will be divided in to Prucalopride and placebo group. An independent treatment code will be generated and allocated according to sample size in each group. Randomization into two groups will be performed by lottery. The independent treatment codes and allocation will be maintained, which will be locked until all analyses will have been completed. Thus, the clinical trial will be performed double-blind with all patients and investigators will unaware of which treatment is allocated.
One group will receive tab Prucalopride 2 mg once daily 30 minute before breakfast, while the other group will receive identical looking placebo one tab once daily at same time. The tablets will be administered for a total of 6 weeks. Before starting treatment each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS-SSS and QOL data will be recorded. Patients will be followed-up at 2 weeks, then at 6 weeks by IBS-SSS questionnaire and IBS-QOL questionnaire. 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 monitored by base line ECG, calculation of corrected QT interval and ECG monitoring (2 weeks and 6 weeks) during the course of treatment. Any adverse event will be responded quickly and documented 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 symptom is determined by the 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 = extremely) that represents one of eight dimensions (dysphoria, interference with activity, body image, health-related worries, food avoidance, social reactions, sexual dysfunction, and relationships). After scoring by the patient, responses will be transformed to reverse code system (5= not at all, 1= extremely). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Its a randomized placebo controlled parallel group clinical trial. Prucalopride group is designated as "A" and placebo group is designated as group "B".
| Arm | Type | Receives |
|---|---|---|
| Prucalopride group (A) | Active comparator | Drug: Prucalopride 2mgPrucalopride 2 mg tablet, once daily in morning before breakfast will use as intervention in arm "A". |
| Placebo group (B) | Placebo comparator | Drug: Prucalopride 2mgPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prucalopride 2mgAlso: PlaceboBoth prucalopride 2mg and placebo will be administered for 6 weeks. Primary outcome will measure at 2nd and 6th week of treatment. | Drug | Placebo group (B), Prucalopride group (A) |
Primary outcome
Assess the Change of IBS symptoms from baseline by using IBS-Symptom Severity Score
Time frame: Base line, during treatment (2nd week) and after 6 weeks
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.
Assess the change of quality of life from baseline by using IBS- Quality of life questionnaire
Time frame: Base line, during treatment (2nd week) and after 6 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof.Dr. Anwarul Kabir, MD study director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prucalopride 2mg in people with Irritable Bowel Syndrome, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ovizit Saha, MBBS (+8801717624559, ovizitsaharmc47@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Change of IBS symptoms from baseline by using IBS-Symptom Severity Score (time frame: Base line, during treatment (2nd week) and after 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.