EUCTR2006-001310-32-LV进行中（未招募）不适用
A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III
Procter & Gamble Technical Centres Limited0 个研究点目标入组 470 人开始时间: 2006年8月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 470
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
- •Patients, who
- •a) are willing and able to provide written informed consent;
- •b) are male or female between 18 and 75 years of age, inclusive, at Screening;
- •c) have a confirmed diagnosis of moderately active ulcerative colitis, extending proximally beyond 15 cm from the anal verge, as confirmed by flexible sigmoidoscopy or colonoscopy performed within 7 days prior to the Baseline Visit.
- •d) have a confirmed diagnosis of moderately active disease (PGA = 2, see Appendix 7.7) at the Baseline Visit;
- •e) have, at the Baseline Visit, a score of at least 1 in both the stool frequency and rectal bleeding clinical assessments and a score of at least 2 in the Sigmoidoscopy Assessment Score (Appendix 7.3);
- •f) if female, must be (as documented by verbally offered medical history):
- •postmenopausal (at least 1 year without spontaneous menses), or
- •surgically sterile (tubal ligation or hysterectomy at least 6 months prior to
- •enrollment), or
- •using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal
- •contraception [at least 3 months prior to enrollment], sexual partner with nonreversed vasectomy [with azoospermia in 2 tests], 2 barrier methods [e.g., condom, diaphragm, or spermicide], or intra-uterine device). Women who are using
- •contraception will be required to have a pregnancy test (urine or serum) at the
- •Screening Visit and at the Week 6/Exit Visit.
- •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
排除标准
- •Patients, who have/are
- •a) received a dose of a product that contains or is metabolized to mesalamine by any route from which more than 1.6 g/day of mesalamine was available within 7 days before the Screening Visit;
- •b) UC confined to rectum (isolated ulcerative proctitis);
- •c) a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
- •d) a history or presence of any condition causing malabsorption or an effect on
- •gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome;
- •e) a current abuser of drugs or alcohol;
- •f) a history of HIV infection or AIDS;
- •g) a significant co-existing illness or other condition(s) that, in the judgment of the
- •Investigator, contraindicate(s) administration of the study drug and/or any study
- •procedures;
- •h) current renal disease (serum creatinine more than 1.5 times the upper limit of normal at Screening Visit) or documented history of hepatic disease (aspartate transaminase [AST] or alanine transaminase [ALT] more than 2 times the upper limit of normal);
- •i) previously participated in this study;
- •j) participated in any drug or device clinical study within 30 days before study entry;
- •k) currently enrolled in any other clinical study;
- •l) received any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days before the Screening Visit;
- •m) received any other topical rectal therapy during the 7 days before the Screening Visit;
- •n) received immunomodulatory therapy including, but not limited to, rosiglitazone,
- •6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 90 days before the Screening Visit;
- •o) received infliximab, certolizumab, or other biologic treatment of ulcerative colitis within 90 days before the Screening Visit;
- •p) received antibiotics, other than topical antibiotics, within 7 days before the Screening Visit;
- •q) used any product containing omega-3 (fish) oils within 7 days before the Screening Visit;
- •r) received aspirin (except for cardioprotective reasons up to a maximum dose of
- •325 mg/day) or other NSAIDs within 7 days before the Screening Visit;
- •s) received any anti-diarrheals, and/or anti-spasmodics within 3 days before the Screening Visit;
- •t) stool examination positive for Clostridium difficile, bacterial pathogens, or ova and
- •u) if female, positive pregnancy test (serum or urine) or lactating
研究者
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