EUCTR2015-002558-11-BE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
Ferring International PharmaScience Center U.S., Inc.0 个研究点目标入组 260 人开始时间: 2015年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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. Satisfied one of the following criteria for enrollment into the trial:
- •a. Met the remission criteria at Week 8 of Study 000174 (Pathway 1) or
- •b. Did not meet the remission criteria during Study 000174 and agreed to an additional 8 weeks of open-label treatment with mesalamine 4 g/day QD, after which met the remission criteria (Pathway 2) or
- •c. Subjects not currently enrolled in Study 000174 and currently treated with medications for UC and currently in remission <1 year based on clinical and endoscopic evaluation (Clinical and Endoscopic Response Score of 0 or 1 and rectal bleeding and stool frequency scores of 0; i.e., clinical and endoscopic remission). The duration of prior remission must be less <1 year and include a history of flare (defined as escalation of medical therapy[ies]), and/or documented episode of recurrent rectal bleeding accompanied by abdominal pain and increased stool number that required medical intervention) (Pathway 3 – de novo)
- •2. Signed informed consent obtained before any trial-related procedures
- •3. Male or nonpregnant female subjects aged 18 to 75 years
- •4. Extent of colonic involvement historically confirmed (i.e., flexible sigmoidoscopy report, colonoscopy report, biopsy reading) within past 12 months
- •5. Estimated creatinine clearance > 60 mL/min
- •6. Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal
- •intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Sterilized or postmenopausal women may also participate. Women must have a negative serum pregnancy test result at screening and negative urine pregnancy test result on baseline/randomization.
- •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 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Evidence of other forms of inflammatory bowel disease
- •2. Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
- •3. Disease limited to proctitis <15 cm
- •4. Short bowel syndrome
- •5. Prior colon resection surgery
- •6. History of severe/fulminant UC
- •7. Intolerant or allergic to aspirin or salicylate derivatives
- •8. Taking the following treatments:
- •a. Aspirin within the past 7 days (except for cardioprotective reasons - maximum dose 325 mg/day)
- •b. Loperamide and other antidiarrheal agents, mucilages, antibiotics (metronidazole and ciprofloxacin), nonsteroidal anti-inflammatory drugs (NSAIDs), nicotine patch within 1 week
- •c. Corticosteroids (oral, intravenous, or intramuscular) within the previous month
- •d. Immunomodulating/suppressing drugs within the previous 6 months
- •e. Use of rectal formulations (5-ASA, steroids) within =7 days
- •f. History of biologics (e.g., Remicade)
- •9. Pathway 3 – de novo only: mesalamine use within 72 hours
- •10. ALT; AST >3 x upper limit of normal (ULN)
- •11. Clinically significant hematological function abnormalities
- •12. Known alcohol or drug abuse
- •13. Women who are pregnant or nursing
- •14. History of or known malignancy (Note: Adequately treated basal cell carcinoma can be included)
- •15. History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders that would interfere with participation in the trial
- •16. Participation in another clinical trial in the last 30 days (except for Study 000174)
- •17. Unable to comply with the requirements of the protocol
- •18. Unable to complete the subject electronic diary or follow data-capturing procedures
研究者
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