EUCTR2009-015158-39-FI进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 reported since the most recent attack:
- •- left lower quadrant pain
- •- fever (higher than 38 °C, ear measurement preferred)
- •- 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 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 720
排除标准
- •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) within the last 2 weeks before inclusion; 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. For patients in need of a CT-scan as part of the protocol, any condition that may increase the risk of conducting the required CT-scan with contrast media. Such conditions include but are not limited to hyperthyroidism, hypersensitivity to CT-scan contrast media, congestive heart failure (NYHA III/IV), and diabetes requiring medication that cannot be safely stopped for the CT-scan
研究者
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