CTRI/2021/11/037831 [Registered on: 08/11/2021] Trial Registered Prospectively
Last Modified On:
02/05/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to evaluate effects of Aspirin and Pantoprazole combination in prevention of gastroduodenal mucosal damage
Scientific Title of Study
A multicenter, randomized, double-blind, double dummy, Phase III study to compare safety and efficacy of fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg versus Aspirin 150mg alone for the prevention of gastroduodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ALK21-ASP1, Version no.1 dated 03.12.2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhilesh Sharma
Designation
President & CMO
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Scientific Query
Name
Dr Vinayaka Shahavi
Designation
ssociate General Manager - Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
vinayaka.shahavi@alkem.com
Details of Contact Person Public Query
Name
Dr Vinayaka Shahavi
Designation
ssociate General Manager - Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
vinayaka.shahavi@alkem.com
Source of Monetary or Material Support
ALkem Laboratories Limited, Mumbai
Primary Sponsor
Name
Alkem Laboratories Limited
Address
Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai-400013
Ward No. 3, Ground Floor, A Block, Clinical Research Department, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Medical Sciences, Wardha-442001, Maharashtra, India Wardha MAHARASHTRA
3rd Floor, Clinical Research department, Belagavi Institute of Medical Science, Dr.B.R.Ambedkar Road, Belagavi-590001, Karnataka, India Belgaum KARNATAKA
9845111575
giridharpatil20@gmail.com
Dr Sunil N Washimkar
Central India Cardiology Hospital and Research Institute
"Research Room, 1st floor, Central India Cardiology Hospital and Research Institute, Plot No. 01, Pioneer Co-op. Housing Society, Gawande Layout, Khamla Ring road, opp. Sawarkar Garden, Khamla, Nagpur-440015 Nagpur MAHARASHTRA
9823065380
sunil_wash@rediffmail.com
Dr C B Kerhavamurthy
Columbia Asia Hospital
No. 85-86, Bangalore-Mysore Ring Road Junction, Bannimantapa A Layout, Siddique Nagar, Mandi Mohalla, Mysuru-570015, Karnataka, India Mysore KARNATAKA
9900152852
cbkeshavamurthy@gmail.com
Dr Mohd Aziz Khan
Crescent Hospital & Heart Centre
Ground floor, Director Consultant chamber, Near Lokmat Square, Dhantoli,
Nagpur-440012, Maharashtra. India Nagpur MAHARASHTRA
91-9823056551
khandraziz@yahoo.com
Dr T Krishna Kumar
Excel Hospital
4th floor, Clinical Research Department, Excel Hospital, 1-5-56/29, Plot No:29, Old Alwal, Near IG Statue, Beside Barat Petroleum, Secunderabad-500010, India Hyderabad TELANGANA
7731030321
doctorresearch1212@gmail.com
Dr Chirag Rathod
GMERS Medical College and Hospital
Clinical Trial Room 01, 6th floor, GMERS Medical College & hospital, Gotri Old TB Hospital Campus, Gotri road, Gotri, Vadodara-390021, Gujarat, India Vadodara GUJARAT
9173765727
chirag.rthd@rediffmail.com
Dr Gouranga Sarkar
Health Point Hospital
Room No. 12, Research Room, OPD Building, Health Point Hospital, 21 Prannath Pandit Street Kolkata 700025 Kolkata WEST BENGAL
9830165760
drgscardio1981@gmail.com
Dr Sankar Chandra Mandal
IPGME&R and SSKM
DClinical Research Room, 2nd Floor, Department of Cardiology, IPGME&R SSKM Hospital, 244, A.J.C Bose Road, Kolkata-700020, West Bengal, India Kolkata WEST BENGAL
9830090626
scmandal5@gmail.com
Dr Ayush Shukla
King Georges Medical University
Research Cell, First Floor, Administrative Block, Department of Cardiology, King Georges Medical University, Shah Mina Rd, Chowk, Lucknow-226003 Lucknow UTTAR PRADESH
9458405101
ayushgeorgian@gmail.com
Dr Amit Kumar Pande
Medipoint Hospital Pvt. Ltd
Third Floor, Research Department, Medipoint Hospital Pvt. Ltd, 241/1, New DP Road, Near Sai Heritage, Aundh, Pune- 411007 Pune MAHARASHTRA
9860918000
dramitkumarpande.pentagon@gmail.com
Dr Priyank Modi
Nirmal Hospital PVT LTD
Clinical Research Room, 5th Floor, Ring Road-395002 Surat GUJARAT
9769977665
modipriyank988@gmail.com
Dr Badal Sahu
NRS Medical College and Hospital
Room No. 11, 6th Floor, Department of General Medicine, Emergency building, NRS Medical College and Hospital, 138, A.J.C.Bose Road, Kolkata-700014, West Bengal, India Kolkata WEST BENGAL
8240184543
drbadal08@gmail.com
Dr Chirag M Patel
Pagarav Hospital & ICU
3rd Floor, Research Department, Plot no.512/1, Nr.G-6 Circle, Opp. SBI Bank, Sector-23, Pagarav Hospital & ICU, Gandhinagar -382026, Gujarat, India Ahmadabad GUJARAT
9099029087
chiragbjmc@gmail.com
Dr Parendar Sirohi
S.P. Medical College
Room No. 27-28, Clinical Research Unit, Department of Medicine, S.P.Medical College & AG of Hospitals, Bikaner 334003, Rajasthan,India Bikaner RAJASTHAN
9461317012
drpsirohi@gmail.com
Dr Sanket Sorate
Sanjeevani Criticare and Research Centre Pvt. Ltd
Clinical Research Room, Ground Floor, Sanjeevani Criticare and Research Centre Pvt. Ltd,
Narayan Sankul, Near Mahalakshni Talkies,
Dindori Road, Panchavati, Nashik-422003
Nashik MAHARASHTRA
Clinical Trial Room No. 01, 2nd floor, New Emergency Building, Department of Medicine, Sir Sayajirao General Hospital, Medical College-Baroda, Jail Road, Indira Avenue, Vadodara-390001 Vadodara GUJARAT
9824083734
ssghospital.ct@spearsmind.com
DrDeepak Kumar Saha
Virinchi Hospital
Cluster E, Ground Floor, Department of Cardiology, Virinchi Hospital, Virinchi Circle, 8-2-672/5-6, Rd Number 1, Shyam Rao Nagar, Banjara Hills, Hyderabad-500034, Telangana, India Hyderabad TELANGANA
9493841512
deepak.saha@virinchi.com
Dr MS Aditya
Yashoda Hospital
Room no. 119, 1st Floor, Yashoda Hospitals, Behind hari Hara Kala Bhavanm Alexandar Road, SP road, Secundarabad, Hyderabad-500003 Hyderabad TELANGANA
A tablet containing Aspirin 150mg to be administered once daily orally, in the morning approximately 1 hour prior to the first meal of the day for 24 weeks.
Intervention
fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg
A capsule containing fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg
To be administered once daily orally, in the morning approximately 1 hour prior to the first meal of the day for 24 weeks.
Inclusion Criteria
Age From
55.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Willing to provide voluntary written informed consent.
2. Willing and able to comply with protocol requirements.
3. Male or female patients with age ≥ 55 years at the time of screening.
4. Patients taking Aspirin ≤ 150 mg daily for ≥3 to ≤6 months and expected to require daily aspirin therapy for at least 6 months
5.Patients requiring continuous low-dose aspirin for the secondary prevention of cardiovascular disease or cerebrovascular disease
a. Patients diagnosed with coronary heart disease, peripheral vascular disease or ischemic stroke or transient ischemic attacks.
b. Or patients with history of:
i. Coronary artery bypass graft (CABG);
ii. Percutaneous coronary intervention (PCI) with or without stent; or
iii. Carotid endarterectomy.
6. Patients with 0 to 10 gastric or duodenum erosion(s) or submucosal hemorrhage(s) (Lanza Score 0 to 2).
Gastro duodenal injury will be determined by endoscopic examination. Gastric and duodenal lesions will be scored using the Lanza (1988) method.
ExclusionCriteria
Details
1. Known hypersensitivity or intolerance to Aspirin, Pantoprazole or related class of drugs or any of the excipients of investigational product.
2. Concurrent erosive or ulcerative esophagitis, esophageal stricture, severe esophagitis, long-segment Barrett’s esophagus, history of serious upper Gastro-intestinal events, such as perforation, or obstruction, pyloric stenosis, previous gastric or duodenal surgery.
3. Use of corticosteroids (except the use of inhaled steroids for asthma), bisphosphonates, acid suppressants, prostaglandin analogues or anticoagulant or any other prohibited medications within last 4 weeks prior to screening or their planned co-prescription during the study participation.
4. Positive test result for H. pylori at Screening.
5. Had a revascularization procedure (i.e., CABG, Percutaneous Transluminal Coronary Angioplasty, or carotid endarterectomy) less than 3 months prior to Screening.
6. Unstable hypertension as judged by Investigator.
7. Uncontrolled diabetes mellitus defined as HbA1c value > 10%.
8. Unstable cardio- or cerebrovascular disease that would endanger the subject if they participated in the trial.
9. Clinically significant valvular disease requiring treatment with anticoagulant.
10. Congestive heart failure (CHF) or other Class III or IV cardiovascular symptoms according to New York Heart Association (NYHA) Functional Classification.
11. Blood coagulation disorder.
12. Any illness with co-prescription of NSAID; Patients who have taken NSAID in last 4 weeks prior to screening.
13. Any psychiatric illness.
14. History of seizure.
15. History of alcoholism or drug addiction within a year prior to enrollment in the study.
16. Severe hepatic dysfunction (i.e., cirrhosis or portal hypertension).
17. Laboratory findings measured at screening:
a. Hemoglobin <10 g/dl
b. Neutrophils < 2000/mm3
c. Platelets <100,000/mm3
d. Total bilirubin > 1.5 X ULN
e. ALT/ AST > 2.5 X ULN
f. Serum creatinine >1.25 X ULN
g. Other than noted specifically, any screening laboratory value that is clinically significant in the Investigator’s opinion and would endanger a subject, if the subject participates in the study
18. Patients with positive serology for HIV, HBV and HCV.
19. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
20. Previous participation in any clinical trial within 1 month before the entry of the study.
21. Any condition that, in the opinion of the Investigator, may have either put the subject at risk or influenced the results of the study.
22. Pregnant or lactating women.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To compare proportion of patients developing gastro duodenal events in both the treatment groups.
12 and 24 weeks
Secondary Outcome
Outcome
TimePoints
Secondary Efficacy Endpoints:
1) Mean change in Lanza Score
2) Proportion of patients worsening in terms of Lanza score from baseline in both groups.
3) Mean change in heartburn score in both groups.
4) Usage of antacid in both groups.
12 and 24 weeks
Safety Endpoint:
1) Treatment emergent serious and non-serious adverse events (AEs)
2) Worsening of clinical laboratory parameters
Throughout the study duration
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A multicenter, randomized, double-blind, double dummy, Phase III study to compare safety and efficacy of fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg versus Aspirin 150mg alone for the prevention of gastroduodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease.
Study is planned in 240 Patients Prevention of gastro duodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease. The study duration will be approximately 1 year considering 6 months of recruitment period, 1 week screening period, 24 weeks of treatment period & 1 week follow-up period