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1 CTRI Website URL Clinical Trial Details (PDF Generation Date : Wed, 14 Nov :48:48 GMT) CTRI Number Last Modified On 23/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/ [Registered on: 25/01/2012] Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Study to determine the efficacy and safety of Dexlansoprazole in Gastroesophageal Reflux patients A RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED, COMPARATIVE, PARALLEL GROUP, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF DEXLANSOPRAZOLE VERSUS LANSOPRAZOLE FOR GASTROESOPHAGEAL REFLUX DISEASE (GERD) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multicenter study) CP/21/10, Version 2.1, Dated Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Jaideep Gogtay Medical Director Cipla Ltd. Phone Fax Designation Affiliation Bellasis Road, Mumbai Central Mumbai India jgogtay@cipla.com Details Contact Person (Public Query) Dr Sunil Gupta Phone Fax Principal Investigator Gastroenterologist Global Gastro & Liver Centre 6/2 Malviya Nagar, Near Amit Bharadwaj Petrol Pump, India sunilgastro@rediffmail.com page 1 / 6

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 (022) / Fax Cipla Ltd Primary Sponsor Details Bellasis Road, Mumbai Central, Mumbai, Phone: (022) / Fax: (022) Type of Sponsor NIL List of Countries India of Principal Investigator Dr Vijay Sharma Dr Sunil Gupta Dr Mahendra Parmar Dr Sandeep Kansal Dr S D Wagle Dr Unmesh Takalkar Pharmaceutical industryindian NIL of Site Site Phone/Fax/ Dr. Vijay Sharma Gastroenterology Clinic Global Gastro & Liver Centre Dr. Vijay Sharma Gastroenterology Clinic, 170, Indira Colony, Jhotwara Road, Bani Park, Global Gastro & Liver Centre, 6/2 Malviya Nagar, Near Amit Bharadwaj Petrol Pump,17 College & SSG Hospital College & SSG Hospital, Department of Medicine, Vadodara GUJARAT College and New Civil Hospital King Edward Memorial Hospital Kodlikeri Memorial Hospital Department of Surgery, College and New Civil Hospital, Majura Gate, Surat, Gujarat Surat GUJARAT King Edward Memorial Hospital, Department of Gastroenterology, TDH Bldg. 1st Floor,Sardar Moodliar Road, Rasta Peth, Pune Kodlikeri Memorial Hospital, 8, 9, Manjeet Nagar, Opp. Akashwani, Jalna Road, Aurangabad vijaysadashiv@gmail.co m sunilgastro@rediffmail.c om mcparmar1961@gmail. com drkansals@rediffmail.co m sdwagle@gmail.com unmesh_3@sancharnet.in page 2 / 6

3 CTRI Website URL Details of Ethics Committee Dr Punit Mehrotra Gastroenterology & Gynecology Centre Gastroenterology & Gynecology Centre, B/127, Nirala Nagar, UTTAR PRADESH Dr Sanjay Salunkhe Noble Hospital Noble Hospital, 153, Magarpatta City Road, Pune Dr Shrish Bhatnagar Dr Ramesh Satarkar Dr Shobna Bhatia Rajajipuram Hospital & Maternity Centre Satarkar Gastroenterology Centre Rajajipuram Hospital & Maternity Centre, E1075, Rajajipuram, UTTAR PRADESH Satarkar Gastroenterology Centre, Antarang,20,Tilak Nagar, Near Savarkar Chowk, Aurangabad Seth G.S. Medical Seth G.S. Medical College & KEM Hospital College & KEM Hospital, Department of Gastroenterology, MS Bldg, 9th Floor, Parel, Mumbai Dr Sandeep Nijhawan SMS Hospital SMS Hospital, JNL Marg, Dr B Ravi Shankar Yashoda Hospital Yashoda Hospital, Behind Hari Hara Kala Bhavan, S.P. Road, Secunderabad Hyderabad ANDHRA PRADESH punmel@yahoo.com drsanjaysalunkhe@gm ail.com drshrishbhatnagar@gm ail.com rpsatarkar@rediffmail.c om sjb@kem.edu drnijhawansandeep@g mail.com b_ravishankar@yahoo. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bio Ethics Forum for Gastroenterology and Gynecology Centre, for Dr. Punit Mehrotra Bio Ethics Forum of, An Independent Ethics Committee (BEFL), Approved 19/02/2012 Yes Approved 16/09/2012 Yes page 3 / 6

4 CTRI Website URL Ethics Committee Kodlikeri Memorial Hospital and CIIGMA Hospital, Aurangabad for Dr. Unmesh Takalkar Approved 28/01/2012 No Ethics Committee of KEM Hospital Research Centre, Pune. for Dr. S D Wagale Approved 23/02/2012 No Human Research Ethics Committee College Surat for Dr Sandeep V. Kansal Committee for Human Research (IECHR) for College & SSG Hospital,Vadodara, Dr. Mahendra Parmar Committee of SMS Hospital, for Dr. Sandeep Nijhawan Committee, Govt. Medical College for Satarkar Gastroenterology Centre, Dr. Ramesh Satarkar, Aurangabad Noble Hospital Committee, Pune for Dr. Sanjay Salunkhe Approved 31/01/2013 No Approved 06/03/2012 No Approved 16/03/2012 No Approved 24/02/2012 No Approved 11/02/2012 No Seth G S Medical College and KEM Hospital, Diamond Jubilee Society Trust Committee, Mumbai Approved 25/01/2012 No Swasthya Kalyan Independant Ethics Committee for Dr. Vijay Sharma Gastroenterology Clinic, Approved 09/02/2012 Yes Swasthya Kalyan Independant Ethics Committee for Global Gastro and Liver Centre, for Dr. Sunil Gupta Yashoda Academy of Medical Education and Research, Hyderabad Approved 16/03/2012 Yes Approved 28/10/2011 No page 4 / 6

5 CTRI Website URL Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Date Approved/Obtained 16/12/2011 Health Type Patients Condition GASTROESOPHAGEAL REFLUX DISEASE (GERD) Type Details Intervention Comparator Agent Age From Age To Gender Details Dexlansoprazole 30mg(NERD) and 60mg(Erosive Oesophagitis) Lansoprazole 15mg(NERD) and 30mg(Erosive Oesophagitis) Year(s) Year(s) Both Inclusion Criteria Note: There is no upper age limit Single Capsule to be taken once daily before breakfast for 8 weeks. Single Capsule to be taken once daily before breakfast for 8 weeks. Screening Visit 1 1. Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any study related procedures. 2. Patients of both the sexes of age 18 years and above, who can read and write. 3. The patients with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 2 months prior to screening. Exclusion Criteria Screening Visit 2 and Baseline Visit 1. The patients who experience heartburn on at least 4 of the 7 days of the screening period. Exclusion Criteria Details Screening Visit 1: 1. Patient chronically using non steroidal anti inflammatory drugs including COX2 inhibitors (greater than 12 doses per month) other than aspirin (less than or equal to 325 mg is allowed) within last 14 days. 2. Need for continuous anticoagulant therapy 3. History of hypersensitivity to study drugs or any of its components 4. Severe unstable or uncontrolled disease 5. History of alcohol or drug abuse or dependence 6. Participation in an investigational study within 30 days prior to screening 7. Female who is pregnant or lactating or planning to become pregnant. 8. Woman of child bearing potential who is unwilling to use adequate methods of contraception. Screening Visit 2 and Baseline Visit 1. Patient with GERD complications like Endoscopic Barretts oesophagus and/or definite dysplastic changes in the oesophagus 2. Patient with ZollingerEllision syndrome or other hypersecretory condition 3. Patient with pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration. page 5 / 6

6 Powered by TCPDF ( PDF of Trial CTRI Website URL Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Prenumbered or coded identical Containers Participant, Investigator and Outcome Assessor Blinded 4. A history of or active gastric or duodenal ulcers within 4 weeks prior or had significant acute upper gastrointestinal hemorrhage within 4 weeks of the baseline endoscopy. 5. Clinically significant laboratory values, as judged by the investigator (as per the assessment on screening visit 2 / Baseline visit) Primary Outcome Outcome Timepoints Mean Change in GSAS questionnaire sum scores (frequency, severity and distress scale) From baseline to 2, 4 and 8 weeks of treatment period. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Percentage of 24 hours heartburn free days From baseline to week 2, 4 and 8 Percentage of days without daytime heartburn From baseline to week 2, 4 and 8 Percentage of nights without night time heartburn From baseline to week 2, 4 and 8 Reduction in mean severity of heartburn From baseline to week 2, 4 and 8 Percentage of Patients who achieved sustained resolution of heartburn (7 consecutive heartburnfree days) Percentage of days without rescue medication use Percentage of treatment emergent adverse events At week 2, 4 and 8 Clinically significant changes in laboratory values Incidence and nature of adverse events Clinically significant changes in vital signs & systemic examinations Total Sample Size=242 Sample Size from India=242 02/04/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable Closed to Recruitment of Participants NIL This study is designed to assess the efficacy and safety of dexlansoprazole versus lansoprazole in patients with Gastroesophageal Reflux Disease (GERD). Total 242 patients will be participating in the study from 13 centers throughout India. The study will consist of 714 days of screening period and 8 weeks of treatment period. The primary endpoint of the study is to determine mean change in GSAS questionnaire sum scores from baseline to week 2, week 4 and week 8. Adverse events will be recorded during entire study period of the study. page 6 / 6