Irritable Bowel Syndrome With DiarrheaPhase 3IRIS-05NCT02320318
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 3 study testing Ibodutant 10 mg in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 20 sites in 3 countries.
Trial summary
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Ibodutant 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Belonging to the Asian race and specifically to the Chinese, Indian and Korean ethnicity.
- Clinical diagnosis of IBS-D according to the following symptoms, based on Rome III modular questionnaire criteria:
- Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics:
- improvement with defecation
- onset associated with a change in the frequency of stool
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- onset associated with a change in form (appearance) of stool.
- Symptom-onset at least 6 months prior to diagnosis.
- Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
- Additional criterion: More than 3 bowel movements per day at least 25% of the time in the last 3 months.
- For patients older than 50 years OR patients with a positive family history of colorectal cancer: Normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years.
- For patients aged 65 years or older: Absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months.
- For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period.
- Physical examination without clinically relevant abnormalities during screening.
- No clinically relevant abnormalities in 12-Lead ECG or in laboratory findings.
- Mentally competent, able to give written informed consent, and compliant to undergo all visits and procedures.
- Unrestricted access to a touch-tone telephone.
- Willingness to refrain from using loperamide within 3 days prior to run-in visit and during the run-in period.
- Additional criteria at randomisation:
- During both weeks of the run-in period:
- A weekly average of worst abdominal pain in the past 24 hours with a score of ≥3.0 on a 0 to 10 point scale.
- At least one bowel movement on each day.
- A weekly average of at least 3 bowel movements per day.
- At least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week.
- Less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
- Adequate compliance with the e-diary recording procedure defined as at least 11 of 14 days (≥75%) of the nominal daily data entry.
Who cannot join
- Male gender.
- Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.
- Colonic or major abdominal surgery, any other major abdominal surgery or elective major surgery planned or expected during the study.
- History of organic GI abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis.
- History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months.
- History of gluten enteropathy or lactose intolerance.
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- Current or previous diagnosis of neoplasia.
- History of endometriosis.
- History of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
- History of human immunodeficiency virus infection.
- History of major cardiovascular events in the previous 6 months.
- Uncontrolled hypertension, insulin-dependent diabetes mellitus or abnormal thyroid function.
- Major psychiatric or neurological disorders or unstable medical condition which may compromise the efficacy and safety assessments.
- Evidence of clinically significant hepatic disease, severe renal insufficiency or anemia.
- Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
- Use of prohibited concomitant medication within the previous month such as antibiotics, antimuscarinic drugs, drugs enhancing GI motility and analgesics.
- Pregnancy or breastfeeding.
- Inability to understand or collaborate throughout the study.
- Participation in other clinical studies in the previous 4 weeks or concomitant enrollment in a clinical study.
- Any condition that would compromise the well-being of the patient.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Taiwan9 sites
Study site
Kaohsiung City, 807
Study site
Kaohsiung City, 83301
Study site
Taichung, 40201
Study site
Tainan, 704
Study site
Taipei, 10002
Study site
Taipei, 104
Study site
Taipei, 11217
Study site
Taoyuan, 333
Study site
Yunlin, 640
South Korea8 sites
Study site
Busan, 602739
Study site
Daegu, 705718
Study site
Gangwon-do, 200704
Study site
Gyeonggi-do, 463712
Study site
Gyeonggi-do, 471701
Study site
Seoul, 110744
Study site
Seoul, 137701
Study site
Seoul, 138736
Singapore3 sites
Study site
Singapore, 258500
Study site
Singapore, 308433
Study site
Singapore, 529889
About this study
Official title: A 12-week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhoea (IBS-D).
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.
Read the detailed description
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment.
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-week overall duration of the study for each patient.
Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Ibodutant 10 mg, Placebo
- Keywords
- Irritable Bowel Syndrome, Colon, irritable, Bowel disease, Diarrhea
- Medical subject headings
- Irritable Bowel Syndrome, Intestinal Diseases, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibodutant 10 mgDrug
Also called MEN 15596
Oral tablet, once daily.
PlaceboDrug
Also called Sugar pill
Oral tablet (identical in appearance and weight to ibodutant tablet), once daily.
| Study group | Role | What they receive |
|---|---|---|
| Ibodutant 10 mg | Experimental | Oral tablet once daily for 12 weeks of treatment. At week 13, patients in the ibodutant 10 mg arm will be re-randomised in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment. Receives: Drug: Ibodutant 10 mg |
| Placebo | Placebo comparator | Oral tablet once daily for 12 weeks of treatment. At week 13, patients in the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant 10 mg for additional 4 weeks of treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly response for abdominal pain intensity AND stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
The patient will be considered a weekly responder if she meets both of the following criteria in the same week:
- Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
- Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Measured: 12-week
Secondary outcomes (4)
Weekly response for abdominal pain intensity over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
The patient will be considered a weekly abdominal pain responder if she meets the following criterion:
- Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.
Measured: 12-week
Weekly response for stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
The patient will be considered a weekly stool consistency responder is she meets the following criterion:
- Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Measured: 12-week
Weekly Response for relief of overall IBS signs and symptoms over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to "completely relieved/improved" or "considerably relieved/improved".
Measured: 12-week
Evaluation of rebound effects
Comparison between average abdominal pain intensity and stool consistency during the 4-week RW treatment period and baseline in patients who are re-randomised to placebo after being treated with ibodutant.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan F Tack, Prof., Study chair, Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320318
- Sponsor's protocol ID
- NAK-08
- Acronym
- IRIS-05
- Status last verified
- May 2016
- First submitted
- 12 Dec 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhoea (IBS-D).
- ClinicalTrials.gov ID
- NCT02320318
- Acronym / sponsor ID
- IRIS-05 / NAK-08
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- Irritable Bowel Syndrome, Colon, irritable, Bowel disease, Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- 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 with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.
Detailed description
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment.
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-week overall duration of the study for each patient.
Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibodutant 10 mg | Experimental | Drug: Ibodutant 10 mgOral tablet once daily for 12 weeks of treatment. At week 13, patients in the ibodutant 10 mg arm will be re-randomised in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment. |
| Placebo | Placebo comparator | Drug: PlaceboOral tablet once daily for 12 weeks of treatment. At week 13, patients in the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant 10 mg for additional 4 weeks of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Female patients aged 18 years or older.
- Belonging to the Asian race and specifically to the Chinese, Indian and Korean ethnicity.
- Clinical diagnosis of IBS-D according to the following symptoms, based on Rome III modular questionnaire criteria:
- For patients older than 50 years OR patients with a positive family history of colorectal cancer: Normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years.
- For patients aged 65 years or older: Absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months.
Key exclusion criteria (20 listed)
- Male gender.
- Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.
- Colonic or major abdominal surgery, any other major abdominal surgery or elective major surgery planned or expected during the study.
- History of organic GI abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis.
- History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months.
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 |
|---|---|---|
| Ibodutant 10 mgAlso: MEN 15596Oral tablet, once daily. | Drug | Ibodutant 10 mg |
| PlaceboAlso: Sugar pillOral tablet (identical in appearance and weight to ibodutant tablet), once daily. | Drug | Placebo |
Primary outcome
Weekly response for abdominal pain intensity AND stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
Time frame: 12-week
The patient will be considered a weekly responder if she meets both of the following criteria in the same week: * Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; * Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
4 secondary outcomes
Weekly response for abdominal pain intensity over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
Time frame: 12-week
Weekly response for stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
Time frame: 12-week
Weekly Response for relief of overall IBS signs and symptoms over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks).
Time frame: 12-week
Evaluation of rebound effects
Time frame: 12-week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
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Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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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.
Jan F Tack, Prof. study chair
Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibodutant 10 mg in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 20 sites in 3 countries.
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 26 inclusion and 20 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: withdrawn, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Taiwan, South Korea, Singapore. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly response for abdominal pain intensity AND stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). (time frame: 12-week). 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 19 May 2016.