Irritable Bowel SyndromePhase 2IRISNCT00761007
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
A Phase 2 study testing Ibodutant in people with Irritable Bowel Syndrome, run by Menarini Group at 6 sites in 6 countries.
Trial summary
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Ibodutant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 554 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 - 70 years.
- Clinical diagnosis of IBS .
- For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
- Use of appropriate contraceptive methods.
- Normal physical examination or without clinically relevant abnormalities.
Who cannot join
- Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
- History of gluten enteropathy.
- Lactose intolerance as assessed by response to diet
- Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
- Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
- Unstable medical condition.
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- Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
- Pregnancy or breastfeeding.
- Patient not able to understand or collaborate throughout the study.
- Participation in other clinical trials in the previous 4 weeks.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Denmark1 site
Center for Clinical and Basic Research (CCBR)
Ballerup Municipality
Russia1 site
Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
Moscow
United Kingdom1 site
Synexus Midlands Clinical Research Centre
Birmingham
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Effect of a 4-week Treatment With Oral Doses of Ibodutant (Code: MEN15596) in Irritable Bowel Syndrome (IBS).
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Ibodutant, Placebo
- Keywords
- Irritable Bowel Syndrome, Bowel disease
- Medical subject headings
- Irritable Bowel Syndrome, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbodutantDrug
Also called Code: MEN 15596
Oral tablet, dose level 1 (10 mg), once daily
IbodutantDrug
Also called Code: MEN 15596
Oral tablet, dose level 2 (30 mg), once daily
IbodutantDrug
Also called Code: MEN 15596
Oral tablet, dose level 3 (60 mg), once daily
PlaceboDrug
Oral tablet matching the three dose levels of ibodutant, once daily
| Study group | Role | What they receive |
|---|---|---|
| Ibodutant 10 mg | Experimental | Not described Receives: Drug: Ibodutant |
| Ibodutant 30 mg | Experimental | Not described Receives: Drug: Ibodutant |
| Ibodutant 60 mg | Experimental | Not described Receives: Drug: Ibodutant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Overall IBS Symptom Relief - 50% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"
Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)
Measured: Four weeks
Secondary outcomes (2)
Response of Overall IBS Symptom Relief - 75% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"
Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Measured: Four weeks
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"
Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Professor, Study chair, Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761007
- Sponsor's protocol ID
- NAK 03
- Other IDs
- 2008-000214-71, 2008
- Acronym
- IRIS
- Status last verified
- Mar 2012
- First submitted
- 25 Sep 2008
- Last updated
- 21 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Effect of a 4-week Treatment With Oral Doses of Ibodutant (Code: MEN15596) in Irritable Bowel Syndrome (IBS).
- ClinicalTrials.gov ID
- NCT00761007
- Acronym / sponsor ID
- IRIS / NAK 03
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 1 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
Detailed description
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibodutant 10 mg | Experimental | Drug: Ibodutant |
| Ibodutant 30 mg | Experimental | Drug: Ibodutant |
| Ibodutant 60 mg | Experimental | Drug: Ibodutant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18 - 70 years.
- Clinical diagnosis of IBS .
- For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
- Use of appropriate contraceptive methods.
- Normal physical examination or without clinically relevant abnormalities.
Key exclusion criteria (10 listed)
- Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
- History of gluten enteropathy.
- Lactose intolerance as assessed by response to diet
- Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
- Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
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 |
|---|---|---|
| IbodutantAlso: Code: MEN 15596Oral tablet, dose level 1 (10 mg), once daily | Drug | Ibodutant 10 mg |
| IbodutantAlso: Code: MEN 15596Oral tablet, dose level 2 (30 mg), once daily | Drug | Ibodutant 30 mg |
| IbodutantAlso: Code: MEN 15596Oral tablet, dose level 3 (60 mg), once daily | Drug | Ibodutant 60 mg |
| PlaceboOral tablet matching the three dose levels of ibodutant, once daily | Drug | Placebo |
Primary outcome
Response of Overall IBS Symptom Relief - 50% Rule
Time frame: Four weeks
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)
2 secondary outcomes
Response of Overall IBS Symptom Relief - 75% Rule
Time frame: Four weeks
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule
Time frame: Four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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 Tack, Professor study chair
Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibodutant in people with Irritable Bowel Syndrome, run by Menarini Group at 6 sites in 6 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Germany, Latvia, Russia, Ukraine and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response of Overall IBS Symptom Relief - 50% Rule (time frame: Four weeks). 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 21 Mar 2012.