CTRI/2019/04/018626已完成3 期
A randomized, multi-centre, open label, two-arm, parallel, clinical study to evaluate the efficacy, safety and tolerability of tacrolimus lipid suspension for enema of Intas Pharmaceuticals Limited, India against CORTENEMA® (Hydrocortisone retention enema) of Anip Acquisition Company, USA in adult patients with mild to moderately active left-sided/distal ulcerative colitis refractory to mesalamine treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female subjects are eligible, if they are greater than or equal to 18 years and less than or equal to 65 years of age.
- •2. Subjects have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole/part of left side of the colon [approximately 60 cm up from the anus (anal verge) to splenic flexure of colon], with mild to moderate active disease.
- •3. Subjects with a Full Ulcerative Colitis Disease Activity Index (UCDAI) score of 4 to 10.
- •4. Rectal bleeding score (based on subject diary) of 1 or more at baseline.
- •5. Mucosal appearance score (based on endoscopy) of 1 point or more at baseline.
- •6. Stool Frequency subscore of 1 or more at baseline.
- •7. Patients who have failed to achieve total resolution of all symptoms to topical and/or oral standard treatment regimen of mesalamine over minimum 4 week duration and are in need of an alternative therapy as per the discretion of the Investigator.
- •8. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at enrolment. Surgically sterile, post-menopausal, or sexually abstinent patient or partner must agree to use a medically appropriate form of birth control from screening until 4 weeks after the last dose of study medication.
- •9. Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening until 4 weeks after the last dose of study medication.
- •10. They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- •11. Subjects with acceptable laboratory parameters.
排除标准
- •1. Documented history of proximal or universal ulcerative colitis (pan colitis),
- •2. Those who receive a Physician rating of disease severity of 3 as part of the modified UCDAI or Full UCDAI aggregate score of 11 or greater (severe disease)
- •3. Patients with known allergy to study drugs or have a history of serious AEs related to their use.
- •4. Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •5. Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
- •6. Patient whose stool contains enteric pathogens or Clostridium difficile toxins.
- •7. History of recurrent Clostridium difficile infection.
- •8. History of biological therapy with agents like infliximab, adalimumab, etanercept, etc. within the previous 8 weeks of screening and patients in need of such therapy during the study period.
- •9. Patients who received systemic steroids or immunosuppressants within the previous 4 weeks of screening.
- •10. Treatment in the last 1 week of screening that included antibiotic, antifungal, or antiparasitic medications.
- •11. Patients having a history of cancer (defined as malignancy), asthma, or bronchospasm.
- •12. Patients not able to withdraw and in need of continuing other immunosuppressants like sirolimus or cyclosporine during the study period.
- •13. Patients with hyperkalemia
- •14. Positive pregnancy test or lactating subjects.
- •15. There is evidence of chemical substance abuse.
- •16. History of failure to retain enemas.
- •17. Patients with Crohn disease.
- •18. Patients with HIV, Hepatitis B and Hepatitis C infection
- •19. Patients, who are currently using potassium sparing diuretics
- •20. Patients with pre existent renal function disorders, liver function disorders, cardiac disease, hypertension, clinically important hematological, metabolic, psychiatric, central nervous system or pulmonary disease.
- •21. Patients who participated in any other clinical or post-marketing study (not only for study drugs but also for medical devices) 30 days before signing the informed consent.
- •22. Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome
研究者
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