Symptomatic diverticular disease defines as patients with recurrent abdominal pain on more then 3 days per month with proven diverticula.
Conditions
Interventions
Trade Name: Salofalk 1000mg granules
Product Name: Mesalazine
Pharmaceutical Form: Granules
INN or Proposed INN: Mesalazine
Concentratio
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Symptomatic diverticular disease with short lived recurrent abdominal pain on 3 or more days a month. 2.18 – 85 years of age. 3.Signed informed consent 4.Presence of at least one diverticulum in the left colon Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 SmPC. 4.Inability to stop NSAIDs (non-steroidal anti-inflammatory agents) or long term antibiotics. 5.The use of immunosuppressant medications, antibiotics and other 5-ASA compouns. 6.Presence of other gastrointestinal inflammatory conditions such as ulcerative colitis, Crohn’s disease and Coeliac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether mesalazine has an effect on inflammation and neural changes seen in the bowel wall of patients with diverticular disease.;Secondary Objective: To assess the effect of Mesalazine on abdominal symptoms of patients with diverticular disease.;Primary end point(s): Difference in change in galanin expression in mucosal nerves from 0 to 12 weeks/withdrawal between mesalazine & placebo treated groups. | — |
Countries
United Kingdom
Outcome results
None listed