Irritable Bowel Syndrome: Ketotifen
ISRCTN | ISRCTN22504486 |
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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
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 566 7375 |
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g.e.boeckxstaens@amc.uva.nl |
Study information
Study design | Randomised, placebo controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | The effect of a mast cell-stabiliser on rectal sensitivity |
Study objectives | To 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) studied | Irritable bowel syndrome (IBS) |
Intervention | Patient 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Ketotifen |
Primary outcome measure | The effect of the mast cell-stabiliser ketotifen on the rectal sensitivity in IBS. |
Secondary outcome measures | 1. 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 date | 01/06/2005 |
Completion date | 01/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 64 |
Key inclusion criteria | 1. 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 criteria | 1. Severe comorbidity 2. Use of sedatives, hypnotics or antihistamines 3. Pregnancy/lactation |
Date of first enrolment | 01/06/2005 |
Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
University/education
University/education
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |