Trial Outcomes & Findings for Ibodutant for Relief of Irritable Bowel Syndrome (IRIS) (NCT NCT00761007)

Last Updated: 2012-03-21

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

554 participants

Primary outcome timeframe

Four weeks

Results posted on

2012-03-21

Participant Flow

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.

Subjects underwent a 2-week screening period to meet inclusion/exclusion criteria and were subsequently randomised.

Participant milestones

Participant milestones
Measure	Ibodutant 10 mg oral tablet, once daily	Ibodutant 30 mg oral tablet, once daily	Ibodutant 60 mg oral tablet, once daily	Placebo oral tablet, once daily
Overall Study STARTED	142	135	139	138
Overall Study Safety (>=1 Dose of Study Medication)	140	135	139	137
Overall Study ITT (>= 1 Assessment Post-Randomisation)	140	133	135	136
Overall Study COMPLETED	129	124	121	131
Overall Study NOT COMPLETED	13	11	18	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibodutant 10 mg n=140 Participants oral tablet, once daily	Ibodutant 30 mg n=133 Participants oral tablet, once daily	Ibodutant 60 mg n=135 Participants oral tablet, once daily	Placebo n=136 Participants oral tablet, once daily	Total n=544 Participants Total of all reporting groups
Age Continuous	43.9 years STANDARD_DEVIATION 13.43 • n=93 Participants	45.0 years STANDARD_DEVIATION 12.66 • n=4 Participants	44.4 years STANDARD_DEVIATION 12.97 • n=27 Participants	43.7 years STANDARD_DEVIATION 13.73 • n=483 Participants	44.2 years STANDARD_DEVIATION 13.18 • n=36 Participants
Sex: Female, Male Female	104 Participants n=93 Participants	79 Participants n=4 Participants	90 Participants n=27 Participants	94 Participants n=483 Participants	367 Participants n=36 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	54 Participants n=4 Participants	45 Participants n=27 Participants	42 Participants n=483 Participants	177 Participants n=36 Participants
IBS-Subtype IBS-Diarrhea	68 participants n=93 Participants	53 participants n=4 Participants	59 participants n=27 Participants	54 participants n=483 Participants	234 participants n=36 Participants
IBS-Subtype IBS-Constipation	37 participants n=93 Participants	44 participants n=4 Participants	34 participants n=27 Participants	50 participants n=483 Participants	165 participants n=36 Participants
IBS-Subtype IBS-Mixed	26 participants n=93 Participants	29 participants n=4 Participants	34 participants n=27 Participants	22 participants n=483 Participants	111 participants n=36 Participants
IBS-Subtype IBS-Unsubtyped	9 participants n=93 Participants	7 participants n=4 Participants	8 participants n=27 Participants	10 participants n=483 Participants	34 participants n=36 Participants

PRIMARY outcome

Timeframe: Four weeks

Population: Intention-to-Treat (N=544)

Outcome measures

Outcome measures
Measure	Ibodutant 10 mg n=140 Participants oral tablet, once daily	Ibodutant 30 mg n=133 Participants oral tablet, once daily	Ibodutant 60 mg n=135 Participants oral tablet, once daily	Placebo n=136 Participants oral tablet, once daily
Response of Overall IBS Symptom Relief - 50% Rule	79 Participants	61 Participants	61 Participants	78 Participants

SECONDARY outcome

Timeframe: Four weeks

Population: Intention-to-Treat (N=544)

Outcome measures

Outcome measures
Measure	Ibodutant 10 mg n=140 Participants oral tablet, once daily	Ibodutant 30 mg n=133 Participants oral tablet, once daily	Ibodutant 60 mg n=135 Participants oral tablet, once daily	Placebo n=136 Participants oral tablet, once daily
Response of Overall IBS Symptom Relief - 75% Rule	53 Participants	39 Participants	37 Participants	48 Participants

SECONDARY outcome

Timeframe: Four weeks

Population: Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)

Outcome measures

Outcome measures
Measure	Ibodutant 10 mg n=68 Participants oral tablet, once daily	Ibodutant 30 mg n=53 Participants oral tablet, once daily	Ibodutant 60 mg n=59 Participants oral tablet, once daily	Placebo n=54 Participants oral tablet, once daily
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule	33 Participants	17 Participants	22 Participants	25 Participants

POST_HOC outcome

Timeframe: Four weeks

Population: 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)

Outcome measures

Outcome measures
Measure	Ibodutant 10 mg n=54 Participants oral tablet, once daily	Ibodutant 30 mg n=43 Participants oral tablet, once daily	Ibodutant 60 mg n=48 Participants oral tablet, once daily	Placebo n=44 Participants oral tablet, once daily
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule	31 Participants	15 Participants	17 Participants	19 Participants

Adverse Events

Ibodutant 10 mg

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Ibodutant 30 mg

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Ibodutant 60 mg

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ibodutant 10 mg n=140 participants at risk oral tablet, once daily	Ibodutant 30 mg n=135 participants at risk oral tablet, once daily	Ibodutant 60 mg n=139 participants at risk oral tablet, once daily	Placebo n=137 participants at risk oral tablet, once daily
Cardiac disorders Atrial fibrillation	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/135 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.72% 1/139 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Nervous system disorders Cerebrovascular accident	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/139 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Investigations Liver function test abnormal	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/139 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/139 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)

Other adverse events

Other adverse events
Measure	Ibodutant 10 mg n=140 participants at risk oral tablet, once daily	Ibodutant 30 mg n=135 participants at risk oral tablet, once daily	Ibodutant 60 mg n=139 participants at risk oral tablet, once daily	Placebo n=137 participants at risk oral tablet, once daily
Gastrointestinal disorders Abdominal pain	2.9% 4/140 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	3.7% 5/135 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	3.6% 5/139 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.73% 1/137 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/139 • Number of events 4 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.5% 2/137 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Musculoskeletal and connective tissue disorders Back pain	2.1% 3/140 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.4% 2/139 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.5% 2/137 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Diarrhea	3.6% 5/140 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.4% 2/139 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/137 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Nervous system disorders Dizziness	0.71% 1/140 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	3.7% 5/135 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.4% 2/139 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Dyspepsia	1.4% 2/140 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.5% 2/135 • Number of events 12 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/139 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.73% 1/137 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Flatulence	0.00% 0/140 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/139 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.5% 2/137 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Nervous system disorders Headache	6.4% 9/140 • Number of events 12 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	5.2% 7/135 • Number of events 10 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	3.6% 5/139 • Number of events 6 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	5.8% 8/137 • Number of events 10 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Infections and infestations Nasopharyngitis	3.6% 5/140 • Number of events 6 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	4.4% 6/135 • Number of events 7 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.9% 4/139 • Number of events 4 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	5.1% 7/137 • Number of events 9 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Nausea	3.6% 5/140 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	4.4% 6/135 • Number of events 7 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/139 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.9% 4/137 • Number of events 5 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.1% 3/140 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.72% 1/139 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.73% 1/137 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
General disorders Pyrexia	1.4% 2/140 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.74% 1/135 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/139 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	1.5% 2/137 • Number of events 2 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Gastrointestinal disorders Vomiting	0.71% 1/140 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/135 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.72% 1/139 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/137 • Number of events 4 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)
Infections and infestations Urinary tract infection	2.1% 3/140 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	2.2% 3/135 • Number of events 3 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.72% 1/139 • Number of events 1 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)	0.00% 0/137 • Four weeks Analysed for the Safety Population (all patients who took at least one dose of study medication, N=551)

Additional Information

Angela Capriati MD PhD, Clinical Research Director

Menarini Group- Clinical Research

Phone: +39 055 5680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60