CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2012/01/002373 [Registered on: 25/01/2012] Trial Registered Prospectively

Last Modified On:

23/08/2013

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Study to determine the efficacy and safety of Dexlansoprazole in Gastroesophageal Reflux patients

Scientific Title of Study

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)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
CP/21/10, Version 2.1, Dated-11.07.11	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query

Name	Dr Jaideep Gogtay
Designation	Medical Director
Affiliation	Cipla Ltd.
Address	Bellasis Road, Mumbai Central Mumbai MAHARASHTRA 400008 India
Phone	02223025412
Fax	02225787855
Email	jgogtay@cipla.com

Details of Contact Person
Public Query

Name	Dr Sunil Gupta
Designation	Principal Investigator - Gastroenterologist
Affiliation	Global Gastro & Liver Centre
Address	6/2 Malviya Nagar, Near Amit Bharadwaj Petrol Pump, Jaipur-17 Jaipur RAJASTHAN 302017 India
Phone	09352027776
Fax
Email	sunilgastro@rediffmail.com

Source of Monetary or Material Support

Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone (022) 23095521/23082891 Fax 02225787855

Primary Sponsor

Name	Cipla Ltd
Address	Bellasis Road, Mumbai Central, Mumbai, Phone: (022) 23095521/23082891 Fax: (022)25787855.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 13
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vijay Sharma	Dr. Vijay Sharma Gastroenterology Clinic	Dr. Vijay Sharma Gastroenterology Clinic, 170, Indira Colony, Jhotwara Road, Bani Park,302016 Jaipur RAJASTHAN	09928015254 - vijaysadashiv@gmail.com
Dr Sunil Gupta	Global Gastro & Liver Centre	Global Gastro & Liver Centre, 6/2 Malviya Nagar, Near Amit Bharadwaj Petrol Pump,17 Jaipur RAJASTHAN	09352027776 0141-2723090 sunilgastro@rediffmail.com
Dr Mahendra Parmar	Government Medical College & SSG Hospital	Government Medical College & SSG Hospital, Department of Medicine, 390001 Vadodara GUJARAT	09824326550 0265-2338868 mcparmar1961@gmail.com
Dr Sandeep Kansal	Government Medical College and New Civil Hospital	Department of Surgery, Government Medical College and New Civil Hospital, Majura Gate, Surat, Gujarat-395001 Surat GUJARAT	09426141644 - drkansals@rediffmail.com
Dr S D Wagle	King Edward Memorial Hospital	King Edward Memorial Hospital, Department of Gastroenterology, TDH Bldg. 1st Floor,Sardar Moodliar Road, Rasta Peth,411011 Pune MAHARASHTRA	09422010844 - sdwagle@gmail.com
Dr Unmesh Takalkar	Kodlikeri Memorial Hospital	Kodlikeri Memorial Hospital, 8, 9, Manjeet Nagar, Opp. Akashwani , Jalna Road,431005 Aurangabad MAHARASHTRA	09822042425 0240-2345223 unmesh_3@sancharnet.in
Dr Punit Mehrotra	Lucknow Gastroenterology & Gynecology Centre	Lucknow Gastroenterology & Gynecology Centre, B/127, Nirala Nagar, 226020 Lucknow UTTAR PRADESH	09415004548 - punmel@yahoo.com
Dr Sanjay Salunkhe	Noble Hospital	Noble Hospital, 153, Magarpatta City Road, 411013 Pune MAHARASHTRA	09822051735 020-66285199 drsanjaysalunkhe@gmail.com
Dr Shrish Bhatnagar	Rajajipuram Hospital & Maternity Centre	Rajajipuram Hospital & Maternity Centre, E-1075, Rajajipuram, Lucknow-226017 Lucknow UTTAR PRADESH	09918208555 - drshrishbhatnagar@gmail.com
Dr Ramesh Satarkar	Satarkar Gastroenterology Centre	Satarkar Gastroenterology Centre, Antarang,20,Tilak Nagar, Near Savarkar Chowk,431005 Aurangabad MAHARASHTRA	09850035282 0240-2354453 rpsatarkar@rediffmail.com
Dr Shobna Bhatia	Seth G.S. Medical College & KEM Hospital	Seth G.S. Medical College & KEM Hospital, Department of Gastroenterology, MS Bldg, 9th Floor, Parel,400012 Mumbai MAHARASHTRA	09869072213 - sjb@kem.edu
Dr Sandeep Nijhawan	SMS Hospital	SMS Hospital, JNL Marg, 302004 Jaipur RAJASTHAN	09829272233 0141-2575466 drnijhawansandeep@gmail.com
Dr B Ravi Shankar	Yashoda Hospital	Yashoda Hospital, Behind Hari Hara Kala Bhavan, S.P. Road, Secunderabad - 500003 Hyderabad ANDHRA PRADESH	09391075600 040-27718929 b_ravishankar@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 13
Name of Committee	Approval Status
Bio Ethics Forum for Lucknow Gastroenterology and Gynecology Centre, Lucknow for Dr. Punit Mehrotra	Approved
Bio Ethics Forum of Lucknow, An Independent Ethics Committee (BEFL), Lucknow	Approved
Ethics Committee Kodlikeri Memorial Hospital and CIIGMA Hospital, Aurangabad for Dr. Unmesh Takalkar	Approved
Ethics Committee of KEM Hospital Research Centre, Pune. for Dr. S D Wagale	Approved
Human Research Ethics Committee Government Medical College Surat for Dr Sandeep V. Kansal	Approved
Institutional Ethics Committee for Human Research (IECHR) for Government Medical College & SSG Hospital,Vadodara, Dr. Mahendra Parmar	Approved
Institutional Ethics Committee of SMS Hospital Jaipur, for Dr. Sandeep Nijhawan	Approved
Institutional Ethics Committee, Govt. Medical College for Satarkar Gastroenterology Centre, Dr. Ramesh Satarkar, Aurangabad	Approved
Noble Hospital Institutional Ethics Committee, Pune for Dr. Sanjay Salunkhe	Approved
Seth G S Medical College and KEM Hospital, Diamond Jubilee Society Trust-Institutional Ethics Committee, Mumbai	Approved
Swasthya Kalyan Independant Ethics Committee for Dr. Vijay Sharma Gastroenterology Clinic, Jaipur	Approved
Swasthya Kalyan Independant Ethics Committee for Global Gastro and Liver Centre, Jaipur for Dr. Sunil Gupta	Approved
Yashoda Academy of Medical Education and Research, Hyderabad	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	GASTROESOPHAGEAL REFLUX DISEASE (GERD),

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dexlansoprazole 30mg(NERD) and 60mg(Erosive Oesophagitis)	Single Capsule to be taken once daily before breakfast for 8 weeks.
Comparator Agent	Lansoprazole 15mg(NERD) and 30mg(Erosive Oesophagitis)	Single Capsule to be taken once daily before breakfast for 8 weeks.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Note: There is no upper age limit 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. Screening Visit 2 and Baseline Visit 1. The patients who experience heartburn on at least 4 of the 7 days of the screening period.

ExclusionCriteria

Details

Screening Visit 1:
1. Patient chronically using non steroidal anti inflammatory drugs including COX-2 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 Zollinger-Ellision 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.
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)

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

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
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 heartburn-free days)	At week 2, 4 and 8
Percentage of days without rescue medication use	During study period.
Percentage of treatment emergent adverse events	During study period.
Clinically significant changes in laboratory values	During study period.
Incidence and nature of adverse events	During study period.
Clinically significant changes in vital signs & systemic examinations	During study period.

Target Sample Size

Total Sample Size="242"
Sample Size from India="242"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

02/04/2012

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

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 7-14 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.