Randomised controlled trial of mesalazine in symptomatic diverticular disease
| ISRCTN | ISRCTN10958581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10958581 |
| EudraCT/CTIS number | 2006-006198-26 |
| ClinicalTrials.gov number | NCT00663247 |
| Secondary identifying numbers | 29856; 086609 |
- Submission date
- 21/04/2010
- Registration date
- 22/04/2010
- Last edited
- 03/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Diverticular disease affects two thirds of those over the age of 65 of whom about 1 in 5 will develop symptoms. These consist of abdominal pain and erratic bowel habit. There is as yet no effective treatment for these symptoms and this study aimed to test the idea that an anti-inflammatory drug called Mesalazine might benefit. Preliminary studies suggested possible benefit but this needed confirmation.
Who can participate?
Patients with known diverticular disease and recurrent abdominal pain and erratic bowel habit.
What does the study involve?
Patients were required to take either Mesalazine or dummy drug (placebo) twice daily for three months. At the beginning of the study, the lower bowel was examined and a small specimen taken from the lining. This was repeated at the end of the study to look at the effect of Mesalazine on the gut lining.
What are the possible benefits and risk?
We hoped that abdominal symptoms would improve. The drug has been used for many years and the side effects are well recognised. About 1 in 10 of the patients would not have tolerated the drug but only rarely (less than 1 time in 1000) would there have been serious side effects.
Where is the study run from?
Queens Medical Centre, Nottingham (UK)
When is the study starting?
August 2008 to January 2011
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Dr Jan Smith
Jan.smith@nottingham.ac.uk
Contact information
Scientific
Nottingham Digestive Disease Centre
C Floor South Block
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 115 823 1090 |
|---|---|
| robin.spiller@nottingham.ac.uk |
Study information
| Study design | Interventional two group parallel randomised double-blinded placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Mechanistic randomised controlled trial of mesalazine in symptomatic diverticular disease |
| Study acronym | SAG44 |
| Study objectives | To undertake a pilot mechanistic, two group parallel design, randomised controlled trial of anti-inflammatory treatment (mesalazine) in individuals with symptomatic diverticular disease to identify markers to assess the relationship between inflammation and symptoms. |
| Ethics approval(s) | Nottingham Regional Ethics Committee 1, 12/10/2007, ref: 07/Q2403/83 |
| Health condition(s) or problem(s) studied | Diverticular disease |
| Intervention | Mesalazine 3 g/day for 3 months Placebo 3 g/day for 3 months Total duration of follow-up is 3 months (12 weeks) in each study arm. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Mesalazine |
| Primary outcome measure | Difference in change in galanin expression in mucosal nerves from 0 to 12 weeks/withdrawal between mesalazine and placebo treated groups. |
| Secondary outcome measures | Differences between mesalazine and placebo groups with respect of changes from 0 to 12 weeks/withdrawal of: 1. Substance P expression in mucosal nerves 2. Cell counts of CD3, CD25, CD68 positive cells, neutrophils and Paneth cells 3. Faecal calprotectin 4. Urine neopterin 5. Serum interleukin-8 (IL-8)/interleukin-6 (IL-6) 6. Abdominal pain, stool frequency amd mean stool consistency 7. Messenger ribonucleic acid (mRNA)/protein expression of inflammatory cytokines |
| Overall study start date | 01/08/2008 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Symptomatic diverticular disease with short lived recurrent abdominal pain on 3 or more days a month 2. Aged 18 - 85 years of age, either sex 3. Signed informed consent 4. Presence of at least one diverticulum in the left colon |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Severe co-morbidity, alcoholism or drug dependence or inability to give informed consent 3. Contraindications to use of mesalazine as detailed in summary of product characteristics (SmPC) 4. Inability to stop non-steroidal anti-inflammatory drugs (NSAIDs) or long term antibiotics 5. The use of specific concomitant medications 6. Presence of other gastrointestinal inflammatory conditions such as ulcerative colitis, Crohn's disease and Coeliac disease |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The University of Nottingham
E Floor, West Block, QMC
Nottingham
NG7 2UH
United Kingdom
Sponsor information
University/education
c/o Paul Cartledge
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Abstract results | abstract | 01/07/2012 | No | No |
Editorial Notes
03/07/2019: Added EudraCT link to basic results (scientific).
07/03/2019: Publication and dissemination plan and IPD sharing statement added.
06/03/2019: Publication reference added.
11/05/2016: No publications found, verifying study status with principal investigator.
