Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
Irritable Bowel Syndrome, Colon, irritable, Bowel disease
Brief summary
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.
Detailed description
The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient. Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.
Interventions
DRUGIbodutant
Oral tablet, low dose, once daily, for 8 weeks
DRUGPlacebo
Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Sponsors
Menarini Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
At start of the run-in period: * Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria: * Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: 1. improvement with defecation; 2. onset associated with a change in the frequency of stool; 3. onset associated with a change in form (appearance) of stool. * Symptom-onset at least 6 months prior to diagnosis. * Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months. * 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 positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy. * Mentally competent, able to give written informed consent. * For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment. * Normal physical examination or without clinically relevant abnormalities. At randomisation: -Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.
Exclusion criteria
* Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery. * History of gluten enteropathy. * Lactose intolerance as assessed by response to diet. * History of positive tests for ova or parasites, or occult blood in the stool. * Previous diagnosis of diabetes mellitus (either type 1 or 2). * Unstable medical condition. * Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease. * Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. * Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Eight weeks | Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule) |
| Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Eight weeks | Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from 0= worst imaginable health state to 100=best imaginable health state. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule) |
| Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule) |
Countries
Bulgaria, Czechia, Denmark, Germany, Italy, Poland, Spain, Sweden
Participant flow
Recruitment details
First subject screened 06/10/2010, first subject randomised 22/10/2010, last subject out 11/05/2012, at 78 study sites in 8 European countries (Bulgaria, Czech Republic, Denmark, Germany, Italy, Poland, Spain, and Sweden)
Pre-assignment details
A run-in period was planned to confirm eligibility criteria. 5 more patients were randomized instead of the planned number (560) because due to the high screen fail rate it was impossible to predict with how many patients the enrollment goal would be reached. Although the enrollment goal was reached these 5 patients in screening continued the study
Participants by arm
| Arm | Count |
|---|---|
| Ibodutant 1 mg oral tablet, once daily | 140 |
| Ibodutant 3 mg oral tablet, once daily | 138 |
| Ibodutant 10 mg oral tablet, once daily | 139 |
| Placebo oral tablet, once daily | 142 |
| Total | 559 |
Baseline characteristics
| Characteristic | Ibodutant 1 mg | Ibodutant 3 mg | Ibodutant 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 13.7 | 47.1 years STANDARD_DEVIATION 13.4 | 47.0 years STANDARD_DEVIATION 12.8 | 44.1 years STANDARD_DEVIATION 14 | 46.0 years STANDARD_DEVIATION 13.5 |
| European Quality of Life Questionnaire 5D (EQ-5D) QoL VAS | 54.5 Scores on a scale STANDARD_DEVIATION 22.9 | 55.5 Scores on a scale STANDARD_DEVIATION 21.9 | 58.1 Scores on a scale STANDARD_DEVIATION 22.9 | 55.3 Scores on a scale STANDARD_DEVIATION 22.3 | 55.8 Scores on a scale STANDARD_DEVIATION 22.5 |
| IBS symptoms at baseline/ randomisation) Abdominal pain score | 2.5 Scores on a scale STANDARD_DEVIATION 0.6 | 2.3 Scores on a scale STANDARD_DEVIATION 0.5 | 2.3 Scores on a scale STANDARD_DEVIATION 0.5 | 2.3 Scores on a scale STANDARD_DEVIATION 0.6 | 2.3 Scores on a scale STANDARD_DEVIATION 0.5 |
| IBS symptoms at baseline/ randomisation) Bloating score | 2.4 Scores on a scale STANDARD_DEVIATION 0.8 | 2.2 Scores on a scale STANDARD_DEVIATION 0.7 | 2.2 Scores on a scale STANDARD_DEVIATION 0.7 | 2.2 Scores on a scale STANDARD_DEVIATION 0.6 | 2.3 Scores on a scale STANDARD_DEVIATION 0.7 |
| IBS symptoms at baseline/ randomisation) IBS symptom severity rate | 2.7 Scores on a scale STANDARD_DEVIATION 0.7 | 2.6 Scores on a scale STANDARD_DEVIATION 0.6 | 2.6 Scores on a scale STANDARD_DEVIATION 0.6 | 2.6 Scores on a scale STANDARD_DEVIATION 0.6 | 2.7 Scores on a scale STANDARD_DEVIATION 0.6 |
| IBS symptoms at baseline/ randomisation) Urgency score | 2.5 Scores on a scale STANDARD_DEVIATION 0.7 | 2.5 Scores on a scale STANDARD_DEVIATION 0.6 | 2.4 Scores on a scale STANDARD_DEVIATION 0.6 | 2.4 Scores on a scale STANDARD_DEVIATION 0.6 | 2.4 Scores on a scale STANDARD_DEVIATION 0.7 |
| IBS-Symptom Severity Scale score | 343.4 Scores on a scale STANDARD_DEVIATION 68.8 | 333.3 Scores on a scale STANDARD_DEVIATION 78.3 | 332.6 Scores on a scale STANDARD_DEVIATION 74.3 | 335.7 Scores on a scale STANDARD_DEVIATION 69.4 | 336.3 Scores on a scale STANDARD_DEVIATION 72.7 |
| Sex: Female, Male Female | 89 Participants | 87 Participants | 79 Participants | 78 Participants | 333 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 60 Participants | 64 Participants | 226 Participants |
| Stool consistency | 5.7 Scores on a scale STANDARD_DEVIATION 0.6 | 5.7 Scores on a scale STANDARD_DEVIATION 0.5 | 5.7 Scores on a scale STANDARD_DEVIATION 0.6 | 5.7 Scores on a scale STANDARD_DEVIATION 0.6 | 5.7 Scores on a scale STANDARD_DEVIATION 0.6 |
| Stool frequency/day | 4.6 bowel movements/day STANDARD_DEVIATION 1.5 | 4.4 bowel movements/day STANDARD_DEVIATION 1.3 | 4.4 bowel movements/day STANDARD_DEVIATION 1.5 | 4.4 bowel movements/day STANDARD_DEVIATION 1.2 | 4.5 bowel movements/day STANDARD_DEVIATION 1.4 |
| Time since onset of IBS symptoms | 6.2 years STANDARD_DEVIATION 7.3 | 6.3 years STANDARD_DEVIATION 7.5 | 6.3 years STANDARD_DEVIATION 6.9 | 4.6 years STANDARD_DEVIATION 6.2 | 5.8 years STANDARD_DEVIATION 7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 141 | 19 / 142 | 29 / 139 | 20 / 143 |
| serious Total, serious adverse events | 0 / 141 | 1 / 142 | 1 / 139 | 3 / 143 |
Outcome results
Primary
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).
Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)
Time frame: Eight weeks
Population: Intention-to-Treat (559)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibodutant 1 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/Yes | 45 participants |
| Ibodutant 1 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/No | 95 participants |
| Ibodutant 3 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/No | 92 participants |
| Ibodutant 3 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/Yes | 46 participants |
| Ibodutant 10 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/Yes | 55 participants |
| Ibodutant 10 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/No | 84 participants |
| Placebo | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/Yes | 39 participants |
| Placebo | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Responders according to the 75% rule/No | 103 participants |
Comparison: Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.p-value: <0.05Mantel Haenszel
Secondary
Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)
Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from 0= worst imaginable health state to 100=best imaginable health state.
Time frame: Eight weeks
Population: Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibodutant 1 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Baseline (randomisation) | 56.4 units on a scale | Standard Deviation 20.6 |
| Ibodutant 1 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Visit 4 | 71.3 units on a scale | Standard Deviation 17.2 |
| Ibodutant 3 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Visit 4 | 72.1 units on a scale | Standard Deviation 18.7 |
| Ibodutant 3 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Baseline (randomisation) | 58.2 units on a scale | Standard Deviation 22 |
| Ibodutant 10 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Baseline (randomisation) | 57.2 units on a scale | Standard Deviation 22 |
| Ibodutant 10 mg | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Visit 4 | 66.7 units on a scale | Standard Deviation 20.7 |
| Placebo | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Baseline (randomisation) | 58.7 units on a scale | Standard Deviation 21.5 |
| Placebo | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Visit 4 | 72.2 units on a scale | Standard Deviation 17 |
Secondary
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population
Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)
Time frame: Eight weeks
Population: Intention-to-Treat (559)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibodutant 1 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/Yes | 72 participants |
| Ibodutant 1 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/No | 68 participants |
| Ibodutant 3 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/No | 77 participants |
| Ibodutant 3 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/Yes | 61 participants |
| Ibodutant 10 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/Yes | 74 participants |
| Ibodutant 10 mg | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/No | 65 participants |
| Placebo | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/Yes | 55 participants |
| Placebo | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Responders according to the 50% rule/No | 87 participants |
p-value: <0.05Mantel Haenszel
Other Pre-specified
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population
Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)
Time frame: Eight weeks
Population: Intention-to-Treat in the female population (333)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibodutant 1 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/Yes | 32 participants |
| Ibodutant 1 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/No | 57 participants |
| Ibodutant 3 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/No | 52 participants |
| Ibodutant 3 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/Yes | 35 participants |
| Ibodutant 10 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/Yes | 37 participants |
| Ibodutant 10 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/No | 42 participants |
| Placebo | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/Yes | 19 participants |
| Placebo | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Responders according to 75% rule/No | 59 participants |
Other Pre-specified
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population
Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week? Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)
Time frame: Eight weeks
Population: Intention-to-Treat in the male population (226)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibodutant 1 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/Yes | 13 participants |
| Ibodutant 1 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/No | 38 participants |
| Ibodutant 3 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/No | 40 participants |
| Ibodutant 3 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/Yes | 11 participants |
| Ibodutant 10 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/Yes | 18 participants |
| Ibodutant 10 mg | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/No | 42 participants |
| Placebo | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/Yes | 20 participants |
| Placebo | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Responders according to the 75% rule/No | 44 participants |