Irritable Bowel Syndrome: Ketotifen
| ISRCTN | ISRCTN22504486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22504486 |
| Protocol serial number | NTR39 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- 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 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ketotifen |
| Primary outcome measure(s) |
The effect of the mast cell-stabiliser ketotifen on the rectal sensitivity in IBS. |
| Key secondary outcome measure(s) |
1. The effect of the mast cell-stabiliser ketotifen on inflammation in rectal biopsy specimen |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
