Double-blind, randomized, placebo-controlled, parallel group, multi-centre 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: Diverticulitis
MedDRA version: 9.1Level: LLTClassification code 10013538Term: Diverticulitis

Registration Number: EUCTR2007-000680-22-LV

Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1.Signed informed consent
2.Man or woman between 40 and 80 years of age
3.Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or 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 rectal 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 appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. 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

Exclusion Criteria

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 tomography1
3.Right-sided diverticulitis
4.Previous colonic surgery (except previous appendectomy, haemorrhoidectomy, and colonic 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 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