Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
02/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G E E Boeckxstaens

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR39

Study information

Scientific title

The effect of a mast cell-stabiliser on rectal sensitivity

Acronym

Study hypothesis

To assess the effect of a mast cell-stabiliser on rectal sensitivity.

Ethics approval

Ethics approval received from local ethics committee

Study design

Randomised, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Ketotifen

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Severe comorbidity
2. Use of sedatives, hypnotics or antihistamines
3. Pregnancy/lactation

Recruitment start date

01/06/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20650926

Publication citations

  1. Results

    Klooker TK, Braak B, Koopman KE, Welting O, Wouters MM, van der Heide S, Schemann M, Bischoff SC, van den Wijngaard RM, Boeckxstaens GE, The mast cell stabiliser ketotifen decreases visceral hypersensitivity and improves intestinal symptoms in patients with irritable bowel syndrome., Gut, 2010, 59, 9, 1213-1221, doi: 10.1136/gut.2010.213108.

Additional files

Editorial Notes