ISRCTN ISRCTN22504486
DOI https://doi.org/10.1186/ISRCTN22504486
Secondary identifying numbers NTR39
Submission date
04/08/2005
Registration date
04/08/2005
Last edited
02/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G E E Boeckxstaens
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 566 7375
Email g.e.boeckxstaens@amc.uva.nl

Study information

Study designRandomised, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effect of a mast cell-stabiliser on rectal sensitivity
Study objectivesTo assess the effect of a mast cell-stabiliser on rectal sensitivity.
Ethics approval(s)Ethics approval received from local ethics committee
Health condition(s) or problem(s) studiedIrritable bowel syndrome (IBS)
InterventionPatient will be randomised to receive either 2, 4 or 6 mg ketotifen twice a day (BID) or placebo for two months. Patients will undergo a barostat before and after treatment. Prior to the barostats six rectal biopsies will be taken via a proctoscope.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ketotifen
Primary outcome measureThe effect of the mast cell-stabiliser ketotifen on the rectal sensitivity in IBS.
Secondary outcome measures1. The effect of the mast cell-stabiliser ketotifen on inflammation in rectal biopsy specimen
2. The effect of ketotifen on IBS-symptoms
Overall study start date01/06/2005
Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants64
Key inclusion criteria1. Fulfilling Rome II criteria of Irritable Bowel Syndrome (IBS)
2. 18 to 65 years of age
3. No other organic abnormalities explaining the complaints
Key exclusion criteria1. Severe comorbidity
2. Use of sedatives, hypnotics or antihistamines
3. Pregnancy/lactation
Date of first enrolment01/06/2005
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
University/education

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2010 Yes No