Condition category
Digestive System
Date applied
21/04/2010
Date assigned
22/04/2010
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
Queen’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robin Spiller

ORCID ID

Contact details

Nottingham Digestive Disease Centre
C Floor South Block
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 115 823 1090
robin.spiller@nottingham.ac.uk

Additional identifiers

EudraCT number

2006-006198-26

ClinicalTrials.gov number

NCT00663247

Protocol/serial number

29856; 086609

Study information

Scientific title

Mechanistic randomised controlled trial of mesalazine in symptomatic diverticular disease

Acronym

SAG44

Study hypothesis

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

Nottingham Regional Ethics Committee 1, 12/10/2007, ref: 07/Q2403/83

Study design

Interventional two group parallel randomised double-blinded placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Mesalazine

Primary outcome measures

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 trial start date

01/08/2008

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/08/2008

Recruitment end date

01/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Digestive Disease Centre
School of Medicine The University of Nottingham E Floor, West Block, QMC
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Paul Cartledge
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 086609)

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

Publication citations

Additional files

Editorial Notes

11/05/2016: No publications found, verifying study status with principal investigator.