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1 CTRI Website URL Clinical Trial Details (PDF Generation Date : Tue, 29 Jan :44:06 GMT) CTRI Number Last Modified On 29/01/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 30/05/2012] Trial Registered Retrospectively No PMS Drug Other To monitor the safety, tolerability and efficacy of Pirfenidone in Idiopathic Pulmonary Fibrosis An observational, PractIce based, Open label, Noncomparative, multicenter study to Evaluate the efficacy, tolerability and safety of pirfenidone in idiopathic pulmonary fibrosis [PIONEER] Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multicenter study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr Raja Dhar Consultant Pulmonologist Department of Pulmonology and Critical Care, Fortis Hospital Department of Pulmonology and Critical Care, Fortis Hospital, #730, Anandapur, EM Bypass Road,Kolkata Kolkata WEST BENGAL Phone Fax docaardee@yahoo.com Details Contact Person (Scientific Query) Dr Jaideep Gogtay Head Medical Services, Cipla Ltd, Mumbai Cipla Ltd, Mumbai Phone Fax Cipla Ltd. Bellasis Road, Mumbai Central, Mumbai Mumbai jgogtay@cipla.com Details Contact Person (Public Query) Mr Rahul Namjoshi Project Manager Phone Fax Medical Services, Cipla Ltd, Mumbai Cipla Ltd.;3rd Floor, Raj Plaza, LBS Marg, Vikhroli West, Mumbai Mumbai (Suburban) page 1 / 5

2 CTRI Website URL Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone Fax Cipla Ltd Primary Sponsor Details Bellasis Road, Mumbai Central, Mumbai, Phone: Fax: Type of Sponsor List of Countries of Principal Investigator Pharmaceutical industryn of Site Site Phone/Fax/ Dr B P Singh Aditya Clinic Aditya Clinic, 16/1451, Indira Nagar, Lucknow (UP) Lucknow UTTAR PRADESH Dr Harjit Dumra Dr K S Satish Ashrai Associates Sparsh Hospital Chest and Maternity Centre Ashrai Associates Sparsh Hospital, 100B, Swastik Society, Opp Samved Hospital, Stadium Commerce Road, Navrangpura, Ahmedabad Ahmadabad GUJARAT Senior Consultant Chest & HIV Physician, Chest & Maternity Centre, 878, V Block, Rajajinagar, Bangalore Bangalore KARNATAKA Dr Raja Dhar Fortis Hospital Consultant Intensivist and Coordinator, Department of Pulmonology and Critical Care, Fortis Hospital, #730, Anandapur, EM Bypass Road, Kolkata Kolkata WEST BENGAL Dr R Vijai Kumar Centre Consultant Centre, 201, 2nd Floor, bps2159@yahoo.com drdumra@yahoo.co.in mamthasatish@gmail.c om docaardee@yahoo.com drvijaipulmo@yahoo.co. in page 2 / 5

3 CTRI Website URL Details of Ethics Committee Dr Murali Mohan Dr Zarir Udwadia Dr Sujeet K Rajan Hospitals Pulmonary Function Testing Laboratory, Hinduja Hospital The Bhatia General Hospital Srimaan Aishwarya Tower, Indira Park Road, Opposite NTR Stadium, Ashok Nagar, Hyderabad, Andhra Pradesh Hyderabad ANDHRA PRADESH Consultant Hospitals, No.258/A, Bommasandra Indusrial Area Anekal Taluk Bangalore Bangalore KARNATAKA Consultant Chest Physician, Pulmonary Function Testing Laboratory, Hinduja Hospital, Veer Savarkar Marg, Mahim, Mumbai, Maharashtra Mumbai (Suburban) The Bhatia General Hospital, G2 Clinic, Tardeo Road, Mumbai Mumbai bvmuralimohan@gmail. com zarirfudwadia@gmail.co m skrajan@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bhatia Hospital Medical Research Society Ethics Committee forthe Bhatia General HospitalDr. Sujeet Rajan BioEthics Forum of Lucknow Independent Ethics Committee (BEFL),Lucknow for Aditya Clinic, Dr. B. P. SinghLucknow Clinical Research Ethics Committee P D Hinduja National Hospital & Medical Research Centre Mumbai for Pulmonary Function Testing Laboratory, Hinduja Hospital Dr. Udwadia Ethics Committee, Bangalore for Approved 20/03/2012 No Approved 24/06/2012 Yes Approved 18/01/2013 No page 3 / 5

4 CTRI Website URL Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria CentreDr. R. Vijai Kumar Ethis Committee, Bangalore for Ashrai Associates Sparsh Hospital Dr. Harjit Dumra. Ethis Committee, Bangalore for Chest and Maternity CentreDr. K. S. Satish Institutional Ethics Committee of Fortis Hospital,Kolkata for Fortis HospitalDr.Raja DharKolkata Medical Ethics Committee,Bangalore for Narayana Hrudayalaya HospitalsDr. Murali Mohan Status Health Type Patients Approved 09/01/2012 No Approved 14/05/2012 No Date No Date Specified Condition Idiopathic Pulmonary Fibrosis (IPF) Type Details Intervention Pirfenidone Tablets 200 mg The initial dose for adults is 200 mg, three times a day (600 mg/day),after a meal. The dose should be gradually increased to a maximum of 600 mg, three times a day (1,800 mg/day). Furthermore, the dose needs to be adjusted depending on the tolerability of the individual patient. Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Note: No Age limit is given in protocol. 1. Written, signed, dated and ethics committee approved data sharing consent obtained from patients before performing any procedures. 2. Patients diagnosed with IPF as per the ATS/ERS/JRS/ALAT criteria 2011guidelines: a. Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity). b. The presence of a UIP pattern on highresolution computed page 4 / 5

5 Powered by TCPDF ( PDF of Trial CTRI Website URL Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details tomography (HRCT) in patients not subjected to surgical lung biopsy. c. Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy. Exclusion Criteria 1.Patients who have received pirfenidone for more than one year before the start of the study. 2.Pregnant or lactating women. 3.Known allergy or hypersensitivity to Pirfenidone or any components of the medication 4.Concomitant use of fluvoxamine 5.Severe hepatic impairment or end stage liver disease 6.Severe renal impairment (CrCl less than 30 ml/min) or end stage renal disease requiring dialysis Primary Outcome Outcome Timepoints Vital Capacity (VC) and Forced Vital Capacity (FVC) At baseline and 3 monthly intervals. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary HRCT At Baseline and week 48 Additional assessments such as Diffusion lung capacity of CO (DLCO)and 6 minute walk test Symptoms Incidence and nature of adverse events Incidence of drug related adverse events. Clinically significant changes in vital signs and laboratory parameters Total Sample Size=150 Sample Size from =150 Post Marketing Surveillance 14/01/2012 No Date Specified Years=1 Months=4 Days=0 Open to Recruitment The study results are not published in any journal. At baseline and 48 weeks At each visit. This study is a an observational practice based study to monitor the safety, tolerability and efficacy of Pirfenidone in Idiopathic Pulmonary Fibrosis. Total 150 patients will be enrolled in the study from 8 centres across. The patient will be prescribed Pirfenidone for treatment duration of 48 weeks. The patients will be called for follow up visits at week 4, week 12, week 24 and week 48. Adverse event monitoring will be done at all visits. page 5 / 5