NCT00761007

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 1, 2010

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

September 25, 2008

Results QC Date

September 8, 2010

Last Update Submit

March 20, 2012

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeBowel disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Response of Overall IBS Symptom Relief - 75% Rule

    Four weeks

  • Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule

    Four weeks

Study Arms (4)

Ibodutant 10 mg

EXPERIMENTAL
Drug: Ibodutant

Ibodutant 30 mg

EXPERIMENTAL
Drug: Ibodutant

Ibodutant 60 mg

EXPERIMENTAL
Drug: Ibodutant

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IbodutantDRUG

Oral tablet, dose level 1 (10 mg), once daily

Also known as: Code: MEN 15596
Ibodutant 10 mg
PlaceboDRUG

Oral tablet matching the three dose levels of ibodutant, once daily

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Center for Clinical and Basic Research (CCBR)

Ballerup Municipality, Denmark

Location

emovis GmbH

Berlin, Germany

Location

Digestive Diseases Center "Gastro"

Riga, Latvia

Location

Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation

Moscow, Russia

Location

Academy of Medical Science of Ukraine

Dnipropetrovsk, Ukraine

Location

Synexus Midlands Clinical Research Centre

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeIntestinal Diseases

Interventions

ibodutant

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Angela Capriati MD PhD, Clinical Research Director
Organization
Menarini Group- Clinical Research
acapriati@menarini-ricerche.it
+39 055 5680

Study Officials

  • Jan Tack, Professor

    Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

March 21, 2012

Results First Posted

October 1, 2010

Record last verified: 2012-03

Locations

DK(1)RU(1)GB(1)DE(1)UA(1)LA(1)