A study of tacrolimus suspension of Intas Pharmaceuticals Limited, India against CORTENEMA® of Anip Acquisition Company, USA in adult patients with inflammation in the digestive tract.
- Conditions
- Health Condition 1: K515- Left sided colitis
- Registration Number
- CTRI/2019/04/018626
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the efficacy of tacrolimus lipid suspension for enema against CORTENEMA® (Hydrocortisone retention enema) in adult patients with mild to moderately active ulcerative colitis refractory to mesalamine treatment.Timepoint: Week 4
- Secondary Outcome Measures
Name Time Method Evaluation of the safety of the patients exposed to the study drugs. <br/ ><br> <br/ ><br>Estimation of the blood level of tacrolimus following its local administration in patients randomized in test arm.Timepoint: Throught the study