Double-blind, dose-response, randomised, placebo-controlled, parallel group, multicentre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis - Mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis
- Conditions
- DiverticulitisMedDRA version: 12.1Level: LLTClassification code 10013538Term: Diverticulitis
- Registration Number
- EUCTR2009-015158-39-GR
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
1. Signed informed consent
2. Man or woman between 30 and 80 years of age
3. Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography
4. Presence of at least one diverticulum of the left colon
5. Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months (Response: normalization of clinical and biochemical parameters)
6. Most recent attack of left-sided uncomplicated diverticulitis documented by medical records
7. 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 ear measurement)
- altered bowel habit (diarrhea, constipation, passage of mucus, or urgency)
- systemic upset (nausea, lethargy)
8. CRP > ULN or leucocytosis (> 10 000/mm³) at the start of the most recent attack
9. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised partner. The investigator is responsible for determining whether the patient has adequate birth control for study participation.
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
1. Chronic inflammatory bowel disease (such as Crohn’s disease, ulcerative colitis)
2. Complicated diverticular disease (diverticulitis with associated abscess, fistula, obstruction or perforation); diverticular abscess to be excluded by computed tomography
3. Right-sided diverticulitis
4. Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps)
5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia)
6. Active colorectal cancer or a history of colorectal cancer
7. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
8. Hemorrhagic diathesis
9. Active peptic ulcer disease, local intestinal infection
10. Asthma if careful medical monitoring is not ensured
11. Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
12. Abnormal renal function (Cystatin C, creatinine > ULN)
13. Severe co-morbidity and/or immobility
14. 5-aminosalicylic acid (5-ASA, mesalazine) containing drugs, glucocorticosteroids, opioid analgesics, laxatives, antidiarrheals, immunosuppressants, or non-steroidal anti-inflammatory drug (NSAIDs; as permanent treatment) since most recent attack of uncomplicated diverticulitis; acetylsalicylic acid (<= 100 mg/day) or paracetamol, inhaled or nasal steroids allowed
15. Baseline stool positive for organisms causing bowel disease
16. Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile
17. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs
18. Existing or intended pregnancy or breast-feeding
19. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
20. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -To compare the efficacy and tolerability of two doses mesalazine granules (1.5 g and 3 g 5-ASA/d) vs. placebo for the prevention of recurrence of diverticulitis<br>;Secondary Objective: -To study safety and tolerability in the form of adverse events and laboratory parameters<br>-To assess patients´quality of life;Primary end point(s): - Proportion of recurrence-free patients at 48 weeks;<br>- Proportion of recurrence-free patients at 96 weeks:<br>Recurrence of diverticulitis, defined as CRP > ULN or leucocytosis (> 10 000/mm³) and recurrence of diverticulitis-like symptoms (left lower quadrant pain, fever) and confirmation by computed tomography
- Secondary Outcome Measures
Name Time Method