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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000214-71 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibodutant 10 mg | Experimental |
| |
| Ibodutant 30 mg | Experimental |
| |
| Ibodutant 60 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibodutant | Drug | Oral tablet, dose level 1 (10 mg), once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Four weeks |
| Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, Professor | Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical and Basic Research (CCBR) | Ballerup Municipality | Denmark | ||||
| emovis GmbH |
Subjects underwent a 2-week screening period to meet inclusion/exclusion criteria and were subsequently randomised.
First subject enrolled 15/07/2008, last subject observed 18/02/2009, at 60 study centres in 9 European countries (Denmark, Germany, Italy, Latvia, Russia, Slovak Republic, Spain, United Kingdom, and Ukraine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibodutant 10 mg | oral tablet, once daily |
| FG001 | Ibodutant 30 mg | oral tablet, once daily |
| FG002 | Ibodutant 60 mg | oral tablet, once daily |
| FG003 | Placebo | oral tablet, once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibodutant 10 mg | oral tablet, once daily |
| BG001 | Ibodutant 30 mg | oral tablet, once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Intention-to-Treat (N=544) | Posted | Number | Participants | Four weeks |
|
Four weeks
Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibodutant 10 mg | oral tablet, once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Capriati MD PhD, Clinical Research Director | Menarini Group- Clinical Research | +39 055 5680 | 9933 | acapriati@menarini-ricerche.it |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C556791 | ibodutant |
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| Ibodutant | Drug | Oral tablet, dose level 2 (30 mg), once daily |
|
|
| Ibodutant | Drug | Oral tablet, dose level 3 (60 mg), once daily |
|
|
| Placebo | Drug | Oral tablet matching the three dose levels of ibodutant, once daily |
|
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) |
| Four weeks |
| Berlin |
| Germany |
| Digestive Diseases Center "Gastro" | Riga | Latvia |
| Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation | Moscow | Russia |
| Academy of Medical Science of Ukraine | Dnipropetrovsk | Ukraine |
| Synexus Midlands Clinical Research Centre | Birmingham | United Kingdom |
| BG002 |
| Ibodutant 60 mg |
oral tablet, once daily |
| BG003 | Placebo | oral tablet, once daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| IBS-Subtype | Number | participants |
|
oral tablet, once daily |
| OG003 | Placebo | oral tablet, once daily |
|
|
| Secondary | 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) | Intention-to-Treat (N=544) | Posted | Number | Participants | Four weeks |
|
|
|
| Post-Hoc | Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 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) | Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189) | Posted | Number | Participants | Four weeks |
|
|
|
| Secondary | 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) | Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234) | Posted | Number | Participants | Four weeks |
|
|
|
| 0 |
| 140 |
| 29 |
| 140 |
| EG001 | Ibodutant 30 mg | oral tablet, once daily | 3 | 135 | 29 | 135 |
| EG002 | Ibodutant 60 mg | oral tablet, once daily | 1 | 139 | 28 | 139 |
| EG003 | Placebo | oral tablet, once daily | 0 | 137 | 26 | 137 |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
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