A Multi-Center, Double-Blind, Double-Mask, Placebo-Controlled, Three-Arm, Parallel-Group, Randomized Study to Evaluate the Therapeutic Equivalence, Efficacy and Safety of a Generic Formulation of Mesalamine Delayed-Release Tablets (800 mg) and Asacol® HD (mesalamine) Delayed-Release Tablets (800 mg) for the Treatment of Patients with Moderately Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 420
- 试验地点
- 27
- 主要终点
- The primary endpoint is the proportion of patients in each of the three treatment groups that achieve overall treatment success at Week 6 defined as clinical improvement from baseline to end of treatment at week 6.
研究概览
简要总结
This study is a randomized, double blind, parallel group, multi-centre trial comparing the safety and efficacy of Mesalamine DR 800 mg in 420 patients with moderate ulcerative colitis that will be conducted in twenty-five centers in India. The primary and secondary efficacy measurements for evaluations of therapeutic equivalence and efficacy analyses will be the Disease Activity Index (DAI) (Mayo) scoring system, consisting of three components (signs and symptoms) that are patient-rated: stool frequency, rectal bleeding, and Patient?s Functional Assessment (PFA); and two components that are clinician-rated: sigmoidoscopy finding and the Physician?s Global Assessment (PGA) of disease activity. The proposed trial will be conducted only in India and a total of 420 patients will be enrolled in this trial. The duration of the treatment period for each patient will be 6 weeks. for The proposed trial would be started in Jun 2010. The current status of all the sites is "Not yet recruiting" i.e. yet to enroll patients in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 18 or older.
- •Patients with established diagnosis of active ulcerative colitis who have recent relapse within 12 weeks before screening.
- •Newly diagnosed patients with sigmoidoscopy and biopsy report suggestive of active ulcerative colitis within 1 year before screening.
- •Positive Mucosal friability based on the Contact Friability Test conducted at verge.
- •Colonic involvement with ulcerative colitis more than 15 cm from the anal verge.
- •Female or male patients who are surgically sterilized or who are prepared to and agree to practice a barrier form of birth control from screening through 30 days (Females) and 90 days (Males), respectively, from the last dose of study medication.
- •Females who are more than 12 months post-menopausal are also eligible to participate in the study.
- •Able to give written informed consent and to comply with the protocol requirements.
- •Patients who are literate and able and willing to complete a paper diary to enter scores during the 14-to 21 days period immediately before randomization and the entire 6-week treatment period.
排除标准
- •Pregnant or nursing females.
- •Patients who have used oral 5-Amino salicylic acid.
- •Patients whom the investigator deems likely to require immunosuppressant therapy.
- •Administration of immunosuppressive agents within the last 6 weeks before randomization.
- •Patients who have used oral corticosteroids within 4 weeks before randomization.
- •Patients taking prescription or over the counter anti-diarrheal agents within 7 days before randomization
- •Use of Antibiotics, other than topical dermatological antibiotics, within 14 days before randomization
- •Patients who receive an experimental drug or procedure within 30days of randomization, or who are likely to receive an experimental drug or procedure during the study through the 30-day period after the final administration of the study medication.
- •Patients with clinically active extra intestinal manifestations.
- •Patients who have had major gastrointestinal surgery except appendectomy and cholecystectomy.
- •Patients with Crohn’s disease, isolated proctitis, an intra-abdominal abscess, or a toxic megacolon.
- •Patients who have a history of active malignancies within 5 years.
- •Patients with clinically significant hepatic, renal, neurological, endocrine or other significant disease that may interfere with the assessment of the study endpoints
- •Patients with infectious ulcerative colitis.
- •Active drug and/or drug abuse
- •Known case of HIV infection or testing positive for HIV antibody.
- •Patients with Hepatitis A, B, C, or E infection.
- •Patients with serum creatinine of more than 1.5 times of upper limit of normal or liver enzymes of more than 2 times upper limit of normal at screening.
结局指标
主要结局
The primary endpoint is the proportion of patients in each of the three treatment groups that achieve overall treatment success at Week 6 defined as clinical improvement from baseline to end of treatment at week 6.
次要结局
- The secondary endpoints are the primary endpoint including patient?s functional assessment as an additional clinical assessment and change in total disease activity index scores from baseline to week 6, with and without patient?s functional assessment.