The objective of the study is to compare the efficacy and tolerability of mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence of diverticulitis. Additionally, the safety and tolerability in the form of adverse events and…
ID
Source
Brief title
Condition
- Diverticular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of recurrence-free patients within 48 weeks: Recurrence of
diverticulitis, defined as CRP > ULN or after leucocytosis and recurrence of
diverticulitis-like symptoms (left lower quadrant pain, fever) with associated
clinical, biochemical parameters or confirmation by ultrasonography or computed
tomography
Secondary outcome
Proportion of patients with recurrence,
Time in study,· Time to recurrence,
Time to recurrence or discontinuation,
Subgroup analysis for number of episodes of diverticulitis in the previous year
(2 episodes vs more than 2 episodes), Subgroup analysis for prompt vs delayed
start of treatment after attack,
Subgroup analysis for inflammatory markers increased vs not increased at
baseline,
Course of ESR,
Course of CRP,
Course of leucocytosis,
Occurrence of diverticulitis-associated fever,
Number of days with left lower quadrant pain,
Number of days with stools of solid consistency,
Number of days with stools of soft or solid consistency,
Number of days with diarrhea (> 3 stools per day),
Number of days with stools of watery consistency,
Average frequency of stools per week,
Amount of used spasmolytics,
Amount of used analgesics,
Worsening of symptoms, e.g., use of antibiotics, hospitalization for underlying
disease, surgery,
Quality of life,
Health assessment,
Assessment of efficacy by investigator and patient.
Background summary
Up to now no evidence based recommendation for the prevention of recurrence of
diverticulitis is available. As inflammation appears to play an important role
in the course of diverticulitis, mesalazine (an anti-inflammatory drug) might
be useful for the treatment and the prevention of recurrence of diverticulitis.
A therapeutic effect could be demonstrated in a few studies, however, these
studies are not evidence-based. Thus, the aim of this study is to examine the
therapeutic effect of mesalazine with state of the art procedures (randomized,
double-blind, placebo-controlled, parallel group).
Study objective
The objective of the study is to compare the efficacy and tolerability of
mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence
of diverticulitis. Additionally, the safety and tolerability in the form of
adverse events and laboratory parameters should be studied. Thirdly, the
patients* quality of life will be assessed.
Study design
This study is a double-blind, randomised, placebo-controlled, parallel group,
multicentre phase III clinical study and is sponsored by Dr. Falk Pharma GmbH,
Germany. The study should start approximately in february/march 2008 and should
last until approximately mid of 2011.
Intervention
One group of patients will administer 2 sachets of 1.5 g mesalacine granules
per day whereas the other group will administer 1.5 g placebo granules per day
during the study (48 weeks).
Study burden and risks
The patients are not exposed to a high risk while they are participating in
this trial. Mesalazine is widely used for treatment of inflammatory bowel
disease. It is already registered in the Netherlands and only few side-effects
are observed. Possible side effects are headache, nausea, diarrhea or rash.
During this study control examinations and blood tests will be performed.
Leinenweberstr. 5
79108 Freiburg
DE
Leinenweberstr. 5
79108 Freiburg
DE
Listed location countries
Age
Inclusion criteria
Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography.
Presence of at least one diverticulum of the left colon.
Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotis and/or dietary modifications within the last 6 months.
3 or more of the following symptoms documented at the start of the most recent attack:
- left lower quadrant pain
- fever (higher than 38°C by rectal measurement)
- altered bowel habit (diarrhea, constipation, passage of mucus, or urgency)
- systemic upset (nausea, lethargy)
CRP > ULN or leucocytosis (> 10 000/mm³) at the start of the most recent attack
Exclusion criteria
Chronic inflammatory bowel disease.
Complicated diverticular disease (diverticulitis with associated abscess, fistula, obstruction or perforation)
Right-sided diverticulitis.
Presence of symptomatic organic disease of the gastrointestinal tract.
Only patients planned for CT: hyperthyroidism, history of hypersensitivity to iodine or iodinated contrast media, congestive heart failure (NYHA III/IV), multiple myeloma, diabetes with need of drug treatment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000680-22-NL |
| ClinicalTrials.gov | NCT00695643 |
| CCMO | NL20513.029.08 |