A clinical trial to study the effects of Mesalamine Delayed-Release Tablets (800 mg) in comparison with Asacol® HD (mesalamine) Delayed-Release Tablets (800 mg) in patients with moderately active ulcerative colitis.
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
Dr Vivekanand Kulkarni (Email: vkantarang@yahoo.co.in)
Antarang Endoscopy Centre, Inside Trade Centre Complex, Station Road, Kolhapur-416001, Maharashtra, India. Phone no: 0231-2656121. Fax no: 0231-2650644
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Dr S M Ravindranath Email ravindranath_sapollohospitalscom
Apollo Specialty Hospital, Padma Complex, 320, Mount Road, Nandamnam, Teyrampet, Chennai, 600035, Tamilnadu, India. Phone no: 044-2433 1740/1763/6119. Fax no: 044-2436242/044-24363646
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Dr Manish Bhatnagar (Email ID: man_bhatnagar@yahoo.com)
Bhatnagar Clinic, 2nd Floor, Kamdhenu Ashram Road, Ahmedabad - 380009, Gujarat, India. Tel No: +91-79-27542966.
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Dr Ajit Sood (Email: ajitsood10@sify.com)
Dayananad Medical College and Hospital, 6-E, Tagore Nagar, Opp new DMC, Ludhiana-141001, Punjab, India. Phone no: 0161- 2304242/2304234/2301749. Fax no: 0161 2300791
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Dr Prabhakar Boddu (Email: bprabhakardr@yahoo.com)
Department of Gastroenterology, Osmania General Hospital, Afzalgunj, Hyderabad-500012, Andhra Pradesh, India. Phone no: 040-24616687 . Fax no: 040-24616687
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Dr Abhijit Chandra (Email: abhijitchandra@hotmail.com)
Department of Surgical Gastroenterology, Chhatrapati Shahuji Maharaj Medical University, Chowk, Lucknow-226003, U.P, India. Phone No: 0522- 2258660. fax No: 0552- 2256116
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Dr Rajesh Dharamshi (Email: rajeshdharmasi@yahoo.co.in)
Dr Rupesh Mehta (Email ID: drrupeshmehta@gmail.com)
Mehta Hospital, 57, Brahmin Mitra Mandal Society, B/W Paldi Bus Stop & Jalaram Mandir, Paldi, Ahmedadabad - 380006, Gujarat, India. Tel No: +91- 79-26586152/7152, 09824022882
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Dr Rajeev Shrivastava (Email ID: rajshri73@yahoo.co.in)
Nagarjuna Hospital, Kanuru, Vijayawada-520007, Andhra Pradesh, India. Tel No: +91-866-2554701.
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Dr Ajit Kukreja (Email: info@ratandeep.com)
Ratandeep Research Institute, "NAKSHATRA" IInd FLOOR , Ganesh Gali, Maninagar Cross Roads, Ahmedabad - 380008, India. Phone No: 079 - 65255678, 25465119. fax No: 079- 22124022
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Dr Mukesh Kalla (Email: drmkalla@rediffmail.com)
S.R. Kalla Memorial Gastro and General, Hospital, 78, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C Scheme, Jaipur-302001, India. Phone No: 0141-5112042. Fax No: 0141-5112043
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Dr Ramesh Satarkar (Email: rpsatarkar@rediffmail.com)
Satarkar Gastroenterology Centre, Antarang, 20-Tilak Nagar, Near Savarkar Chowk, Aurangabad- 431005, India. Phone no: 0240 2354402/2339885. Fax No: 0240-2354453
Central India Medical Research Ethics Committee, Nagpur
Approved
Citizen's Non-Institutional Independent Ethics Committee, Pune
Submittted/Under Review
Ethics Committee , Shri Siddhivinayak Ganapati Cancer Hospital, Miraj
Approved
Ethics Committee of Manipal Hospital and Manipal Heart Foundation, Bangalore
Submittted/Under Review
Ethics Committee, Osmania General Hospital, Hyderbad
Approved
Heart First Ethics Committee, F-10, Mezzanine Floor, Sheron Plaza, Next to D. Khushaldas Jewelers, Opp Ambikaniketan Bus Stop, Athwalines Road, PArle Point, Surat-395007, Gujrat, India.
1. Male or female patients aged 18 or older.
2. 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.
3. Positive Mucosal friability based on the Contact Friability Test conducted at verge. 4. Colonic involvement with ulcerative colitis more than 15 cm from the anal verge.
5. 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.
6. Able to give written informed consent and to comply with the protocol requirements.
7. 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.
ExclusionCriteria
Details
1. Pregnant or nursing females.
2. Patients who have used oral 5-Amino salicylic acid.
3. Patients whom the investigator deems likely to require immunosuppressant therapy.
4. Administration of immunosuppressive agents within the last 6 weeks before randomization.
5. Patients who have used oral corticosteroids within 4 weeks before randomization.
6. Patients taking prescription or over the counter anti-diarrheal agents within 7 days before randomization
7. Use of Antibiotics, other than topical dermatological antibiotics, within 14 days before randomization
8. 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.
9. Patients with clinically active extra intestinal manifestations.
10. Patients who have had major gastrointestinal surgery except appendectomy and cholecystectomy.
11. Patients with Crohn’s disease, isolated proctitis, an intra-abdominal abscess, or a toxic megacolon.
12. Patients who have a history of active malignancies within 5 years.
13. Patients with clinically significant hepatic, renal, neurological, endocrine or other significant disease that may interfere with the assessment of the study endpoints
14. Patients with infectious ulcerative colitis.
15. Active drug and/or drug abuse
16. Known case of HIV infection or testing positive for HIV antibody.
17. Patients with Hepatitis A, B, C, or E infection.
18. 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.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
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.
Secondary Outcome
Outcome
TimePoints
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.
Total Sample Size="420" Sample Size from India="420" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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.