CTRI/2024/02/062543 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On:
19/09/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Effect of Fexuprazan tablets in Comparison to Esomeprazole Tablets for treatment of patients with Erosive Esophagitis
Scientific Title of Study
A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel, Double-Blind,
Double-Dummy, Comparative Study to Evaluate Efficacy And Safety of Fexuprazan Tablets in Comparison to Esomeprazole Tablets in Patients With Erosive Esophagitis
Trial Acronym
FIERCE study
Secondary IDs if Any
Secondary ID
Identifier
ICR/23/007, Version No.1.0; Dated 23/AUG/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Shruti Saha
Designation
Medical Monitor – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Shruti.Saha@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2 – Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited, Sun House, 201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House, 201 B/1, Western Express Highway, Goregaon ( E),Mumbai 400 063
Ashwin Multispecialty Hospital, No 545, BKR Nagar, Alamu Nagar Road, Sathy Main Road, Coimbatore-641012, TamilNadu, India. Coimbatore TAMIL NADU
9600232224
drganeshmuniappan.acr@gmail.com
Dr Tryambak Samantha
Dr Tryambak Samantha
Department of Medical Gastroenterology Medical College, Kolkata, 88 College Street, Kolkata-73, West Bengal, India. Kolkata WEST BENGAL
8777530352
drts.india@gmail.com
Dr P Shravan Kumar
Gandhi Hospital
In Patient Block, 4th Floor, Department of Neurology, Musheerabad, Secunderabad, Telangana-500003 Hyderabad TELANGANA
8897930875
anithaneuroclinic@gmail.com
Dr Godbole Varsha Yogesh
GMERS Medical College &and Hospital
Department of Medicine, 7th floor hospital building GMERS Medical College and Hospital, Gotri, Vadodara, Gujarat-390021 Ahmadabad GUJARAT
9879181673
drvgodbole@gmail.com
Dr Parul Mitesh Bhatt
GMERS Medical College and Civil Hospital
GMERS Medical College and Civil Hospital, Department of Medicine, Sola, Near Gujarat High Court, Sola gram road, Ahmedabad, 380060 Ahmadabad GUJARAT
9879599595
parulbhatt30@yahoo.com
Dr Anumula Kavitha
Government General Hospital
Room No-220, GMCANA building, Government General Hospital, Guntur, Ap-522001 Guntur ANDHRA PRADESH
9399977555
jananigastro@ymail.com
Dr Vinay Kumar
GSVM medical college
Room No 12, ground Floor, Post graduate department of Medicine, GSVM medical college, Swaroop Nagar, Kanpur UP-208002 Kanpur Nagar UTTAR PRADESH
8726555577
dr.vinayksacchan@gmail.com
Dr Mehta Vatsal Kirit Kumar
Health 1 Super Specialty Hospital
Health 1 Super Specialty Hospital, Near Venitian Villa, Shilaj Circle, S.P Ring Rd, Thaltej, Ahmedabad, Gujarat- 380059 Ahmadabad GUJARAT
7567546444
vatsalmehta6387@gmai.com
Dr Shekhar Puri
Janta Hospital and Maternity Centre
Janta Hospital and Maternity Centre, Near Water Head Tank, Amara Akhari Bypass, Chunar Road, Varanasi-221011, UttarPradesh, India Varanasi UTTAR PRADESH
9532310199
jantahospitalvns@gmail.com
Dr Seetaram NK
KIMS
Department of general Medicine, KIMS, Vidyanagar, Hubli, Karantaka-590022 Dharwad KARNATAKA
KLES Dr Prabhakar Kore Hospital and MRC, Nehru Nagar Belagavi-590010 Karnataka, India.
Belgaum KARNATAKA
09448111913
drsantoshhajare@gmail.com
Dr Vivek Bhatia
Maharaja Agrasen Hospital
Maharaja Agrasen Hospital, West
Punjabi Bagh ,New Delhi-110026
New Delhi DELHI
9811028897
drvivekbhatia@yahoo.co.in
Dr Gupta Dhaval Vinaykumar
Mission Gastro Hospital
Mission Gastro Hospital, 603, Golden Icon, Opp. Medilink Hospital, Between Shivranjani- Shyamal Cross Road, 132 Feet Ring Road, Satellite, Ahmedabad-380015. Ahmadabad GUJARAT
9819277795
drdhavalgupta@gmail.com
Dr Gaurav Garg
Motilal Nehru Medical College
George town Civil Lines, Prayagraj, Uttar Pradesh-211002 Allahabad UTTAR PRADESH
9528767749
drgauravmln@gmail.com
Dr Pinaki Roy
Nil Ratan Sarcar medical collage and Hospital
Nil Ratan Sarcar medical college and Hospital, Department of Gastroenterology, 138 AJC Bose Road Kolkata, 700014 Kolkata WEST BENGAL
8777423258
Drpinaki1979@gmail.com
Dr Manoj Kolhe
Ojas Multispeciality Hospital
Ojas Multispeciality Hospital, Bhondave Chowk, DY Patil College Road Ravet, Pune-412101 Pune MAHARASHTRA
9099058141
manojck008@gmail.com
Dr Gyan Prakash Rai
Om Surgical Center and Maternity Home
Om Surgical Center and Maternity Home, SA-17-3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Road, Varanasi-221007, Uttar Pradesh, India Varanasi UTTAR PRADESH
9828358410
gprai2992@gmail.com
Dr Anupam Kumar Singh
Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh-160012. Chandigarh CHANDIGARH
8284822540
anupam.pgi@gmail.com
Dr Rajesh P
Rajalakshmi hospital & Research Center
#21/1 Lakshmipura Main Road, Vidyaranyapura Post, Bangalore-560097 Bangalore KARNATAKA Bangalore KARNATAKA
9738877298
Siddu.shetty.jaya@gmail.com
Dr Mukesh Kumar Jain
S.M.S. Superspeciality Hospital
S.M.S. Superspeciality Hospital, Department of
Gestroenterology, Vivekanand marg, C-Scheme, Jaipur,
Rajasthan, India -302004 Jaipur RAJASTHAN
9414323607
drmukeshjaingastro@gmail.com
Dr Ashish Joshi
S.P. Medical College and A.G. of Hospitals
S.P. Medical College and A.G. of Hospitals, Department of Gastroenterlogy, Bikaner, Rajasthan–334001 Bikaner RAJASTHAN
9414248526
drashishspmc69@gmail.com
Dr Vyas Kaushal Yogeshbhai
Sardar Vallabhbhai Patel Institute of Medical Science and Research
Sardar Vallabhbhai Patel Institute of Medical Science and Research, Elisbridge, Ahmedabad-380006 Ahmadabad GUJARAT
9825005163
kaushalv27@yahoo.com
Dr Shah Parth Kirti Kumar DNB
Sheth Vadilal Sarabhai General and Sheth Chinai Maternity Hosptial
Sheth Vadilal Sarabhai General and Sheth Chinai Maternity Hosptial, Ellis Bridge, Ahmedabad-380006. Ahmadabad GUJARAT
9924939099
doctorparthshah@gmail.com
Dr Sasi Anand D
Silverline Hospital
Silverline Hospital, No 23 C, 4th cross, West Extention, Thillai Nagar, Trichy-620018, (Gastro room No 1) Tiruchirappalli TAMIL NADU
9841799427
Drsash79@yahoo.co.in
Dr Anil Arora
Sir Ganga Ram Hospital
Department of gastroenterology, Rajinder Nagar, New Delhi 110060, India Central DELHI
9811047385
dranilarora50@gmail.com
Dr Lokesh LV
Sparsh Super Specialty Hospital
Sparsh Super Specialty Hospital, 146 Infantry Road Opposite to police commissioners office, Bangalore, Karnataka-560001 Bangalore KARNATAKA
9606197707
sparshclinical@gmail.com
Dr Haribhakti Das
Sriram Chandra Bhanja Medical Collage and Hospital
Sriram Chandra Bhanja Medical Collage and Hospital. CK-7 Medical College, Cuttack, Odisha-753007 Cuttack ORISSA
9861156676
hbsrho@yahoo.co.in
Dr Mangulkar Mahesh Sudhakarrao
Supe Heart and Dibetes Hospital and Research Centre
Supe Heart and Dibetes Hospital and Research Centre, Opposite Aadharashram, Gharpure Ghat, Near Rungtha School, Ashok Stambh, Nasik-422002, Maharashtra, India Nashik MAHARASHTRA
8087537224
drmaheshmagulkar22@gmail.com
Dr Make Naveen Chand
Visakha Institute of Medical Sciences
Department of gastroenterology Hanumanthwaka, Visakhapatnam-530040, Andhra Pradesh Visakhapatnam ANDHRA PRADESH
Esomeprazole 40 mg tablet and matching placebo tablet for Fexuprazan.
One tablet of Esomeprazole tablets 40 mg and matching placebo for Fexuprazan to be taken approximately 1 hour before the first meal of the day for 8 Weeks.
Intervention
Fexuprazan 40 mg tablet and matching placebo tablet for Esomeprazole.
One tablet of Fexuprazan 40 mg and matching placebo for Esomeprazole to be taken orally OD approximately 1 hour before the first meal of the day for 8 Weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent
2. Patients with erosive GERD on the upper GI endoscopy at Screening
3. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till EOS (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]).
4. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e. not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
ExclusionCriteria
Details
1. Patients having hypersensitivity or any other contraindication to any of the Investigational product or its component
2. Patients taking any treatment for GERD modifying gastric acid secretion (such as oral antacids, PPIs etc) within 7 days prior to Randomization
3. Patients with current or past history of
a) GERD complications like Barrett’s esophagus (Greater than 3 cm) and or definite dysplastic changes in the esophagus
b) Acute peptic ulcer and or ulcer complications (like ulcer related stenosis)
c) Active gastric or duodenal ulcers within 4 weeks prior to Screening
d) Increased GI motility eg in patients with GI hemorrhage, mechanical obstruction or perforation
e) Active GI bleeding or GI bleeding within 4 weeks prior to Screening
f) Inflammatory bowel disease or irritable bowel syndrome
g) Atrophic gastritis or gastric malignancy or any other GI malignancy
h) Zollinger-Ellision syndrome or any other hypersecretory condition
i) Pyloric stenosis, eosinophilic esophagitis, esophageal stricture, Schatzkis ring, esophageal varices, hiatus hernia, achalasia (esophageal motility disorder)
j) Gastric acid suppression surgery
4) Patient with alarm features in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the GI tract
5) Patients with history of any bleeding disorder
6) Patients with conditions requiring surgical treatment or planned surgery during the study duration
7) Patient chronically using (Greater than 5 doses on demand or for 3 consecutive days) systemic steroids or nonsteroidal anti-inflammatory drugs which included COX-2 inhibitors other than aspirin (Less than or equal to 165 mg per day is allowed) within last 28 days prior to Screening
8) Patients taking high dose methotrexate, bisphosphonate, strong CYP3A4 or CYP2C19 inhibitors, CYP3A4, CYP2B6, CYP2D6 or CYP2C19 inducers, agents affecting digestive organs (e.g. M3 receptor antagonists, prokinetics, anticholinergic agents, prostaglandins, mucosal protective agents), anticoagulant therapy or clopidogrel within 14 days (or 5 half lives of particular drug, whichever is longer) prior to Screening or required to take during the study
9) Patients with history of any surgical condition that, in the judgement of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs
10) Patients with history of any clinically significant medical and/or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: cardiovascular disorders (like long QT syndrome, myocardial infarction, angina, etc.), respiratory impairment, hepatic impairment, epilepsy or seizure disorder or any neurological disorder, haematological disorder, metabolic disorder (like thyroid disorder), uncontrolled diabetes (HbA1c Greater than or equal to 9%)]
11) Patients with history of osteoporosis or hypomagnesemia
12) Pregnant and or lactating female
13) Patient with history of HIV and or HBV and or HCV
14) Patient with history of malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy [Note: Patients who have been in remission for more than 5 years and not received any cancer treatment in last 5 years prior to screening can be included in the study]
15) Patient with known alcohol or other substance abuse within last one year prior to Screening
16) Patient who have participated in another Investigational study within the 3 months prior to Screening or planning to participate in another clinical trial during the study
17) Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Cumulative proportion of patients with endoscopically confirmed healed EE [Time frame: Upto Week 8]
Upto Week 8
Secondary Outcome
Outcome
TimePoints
Cumulative proportion of patients with endoscopically confirmed healed EE
Upto Week 4
Proportion of 24 hours (with neither daytime nor nighttime) heartburn free days
Baseline, Weeks 4 and 8
Proportion of days without nighttime heartburn
Baseline, Weeks 4 and 8
Proportion of days without daytime heartburn
Baseline, Weeks 4 and 8
Proportion of 24 hours (with neither daytime nor nighttime) regurgitation free days
Baseline, Weeks 4 and 8
Proportion of days without nighttime regurgitation
Baseline, Weeks 4 and 8
Proportion of days without daytime regurgitation
Baseline, Weeks 4 and 8
Proportion of patients who achieved sustained resolution of heartburn (7 consecutive heartburn free days [24-hour period])
Weeks 4 and 8
Proportion of patients who achieved sustained resolution of regurgitation (7 consecutive regurgitation-free days [24-hour period])
Weeks 4 and 8
Proportion of days without rescue medicines
Baseline, Weeks 4 and 8
Change from Baseline in FSSG Score
Baseline, Weeks 4 and 8
Change from Baseline in the GERD-HRQOL questionnaire
Baseline, Weeks 4 and 8
Proportion of responders (Very much improved, or much improved) as per CGI-I Scale
Weeks 4 and 8
Proportion of patients with TEAEs and SAEs
Throughout the study period
Target Sample Size
Total Sample Size="210" Sample Size from India="210" 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
This study will be a phase III,
randomized, parallel-group, multi-center, double-blind, double-dummy, two-arm, active-controlled,
comparative study. The study will be conducted at approximately 15-20 centers in
India, having qualified Investigators. The study will be initiated only after
the receipt of Regulatory and Ethics committee (EC) approval.
Screening period:
The patient will be screened only
after obtaining written informed consent. After obtaining consent, the patients
will undergo a screening period of minimum 7 days and maximum 14 days. At
screening visit, study-specific screening (including inclusion and exclusion
criteria, medical and surgical history, demography, vital signs and physical examination,
laboratory examination, 12-Lead ECG) will be performed.
Treatment
period:
After confirming the eligibility,
patients will be randomized by allotting the randomization number.Patients will be
either randomized to Test arm (Fexuprazan 40 mg) OR to Comparator arm
(Esomeprazole 40 mg). During the study, assessments will be performed as
planned in the study.