EUCTR2005-003724-19-CZ进行中（未招募）不适用
A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol
Otsuka Maryland Research Institute, Inc.0 个研究点目标入组 375 人开始时间: 2005年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 375
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. Male or female subjects, 18 to 80 years of age, inclusive, who provide written, informed consent prior to any study-related procedures and who are, in the opinion of the Investigator, likely to comply with all the requirements of the study.
- •2. Subjects with established diagnosis of active ulcerative colitis, who have relapsed within 12 weeks before screening. All subjects must have had the diagnosis of ulcerative colitis established by colonoscopy prior to randomization. (Newly diagnosed subjects are also eligible.) Colonoscopy may be substituted for flexible sigmoidoscopy during Screening in order to meet this criteria.
- •3. Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge.
- •4. Subjects with a score ³ 2 for rectal bleeding and a score ³ 2 on flexible sigmoidoscopy at the Screening/Baseline Visit, based on the DAI criteria.
- •5. Subjects who have been on a stable dose of oral 5-ASA for at least 14 days prior to the Screening/Baseline, OR subjects who have not been receiving treatment with 5-ASA for at least 14 days.
- •6. Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening/Baseline Visit through 30 (females) and 90 (males) days, respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal (documented by FSH) are also eligible to participate in the study. [See Section 5.4 of the protocol for a description of acceptable forms of birth control.]
- •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
- •1. Subjects who have severe disease, defined as a DAI of 12 at the Screening/Baseline Visit, and/or subjects whom the Investigator deems likely to require immunosuppressant therapy including corticosteroids and/or hospitalization during the period of study
- •2. Subjects who have any other clinically significant disease(s) or condition/procedure(s) which, in the opinion of the Investigator, could compromise the subject’s involvement in the study and/or interfere with the absorption of the study drug or the overall interpretation of the data
- •3. Subjects who have had major gastrointestinal surgery including, but not limited to, a colostomy, an ileostomy or previous colonic surgery other than appendectomy
- •4. Subjects who have used oral corticosteroids (including oral budesonide) within 30 days, or topical intrarectal agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 7 days of Screening/Baseline [Topical dermatological corticosteroids are not excluded]
- •5. Subjects who have used immunosuppressants within 28 days or IL-10, IL-11, FK-506 [tacrolimus], mycophenolate, cyclosporin, anti-TNF-a or monoclonal antibody medications within 60 days of Screening/Baseline
- •6. Subjects who have a history of active malignancies within 5 years (surgically-treated basal cell, squamous cell, non-melanoma or in situ cervical carcinomas permissible), an intra-abdominal abscess, a toxic megacolon, or a clinical instability resulting from any other cause
- •7. Subjects with a known or suspected history of sclerosing cholangitis
- •8. Subjects with a known history of, or suspected, clinically relevant cardiac disease
- •9. Subjects with a positive stool culture for any enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin (a positive EIA that is subsequently confirmed by a positive cytoxin assay)
- •10. Subjects with partial bowel obstruction, as documented by proximal small bowel dilatation at Screening/Baseline
- •11. Female subjects who are pregnant or lactating
- •12. Female subjects who are likely to undergo an in vitro fertilization (IVF ) procedure from the Screening/Baseline Visit through 30 days after the last dose of study medication, OR male subjects likely to participate in an IVF procedure from the Screening/Baseline Visit through 90 days after the last dose of study medication
- •13. Subjects with compromised hepatic function, characterized by ALT and/or AST levels twice (2x) the upper normal limit and/or a serum bilirubin > 1.7 mg/dL (unless the subject has been diagnosed with Gilbert’s syndrome) based on clinical laboratory results
- •14. Subjects with compromised renal function, characterized by serum creatinine levels 1.5 times the upper normal limit
- •15. Subjects with a platelet count <100,000 or >750,000/mm3 based on clinical laboratory results
- •16. Subjects with severe anemia, defined as hemoglobin of <8.0 g/dL based on clinical laboratory results
- •17. Subjects with a serum albumin <2.5 g/dL based on clinical laboratory results
- •18. Subjects with a prothrombin time INR > 1.2 based on clinical laboratory results
- •19. Subjects with a neutrophil count of <2000/mm3 based on clinical laboratory results
- •20. Subjects taking ³ 325 mg aspirin/day or chronic (³ 7 consecutive days) NSAID use within 7 days of Screening/Baseline
- •21. Subjects who have used antibiotics, other than topical antibiotics for dermatological use, within 14 days of Screening/Baseline
- •22. Subjects taking warfarin within 7 days of the Screening/Baseline Visit
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