CTRI/2025/09/094603 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On:
06/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To check Effectiveness and safeness of Zastaprazan in Comparison to Esomeprazole in Patients with Erosive Esophagitis
Scientific Title of Study
A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel, Double-Blind, Double- Dummy, Phase III, Comparative Study to Evaluate Efficacy and Safety of Zastaprazan in Comparison to Esomeprazole in Patients with Erosive Esophagitis
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/24/007 Version No.1.0, Dated: 10/FEB/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President and Head_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243245598
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Medical Monitor – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited.(SPLL)
Primary Sponsor
Name
Sun Pharma Laboratories Limited. (SPLL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Institutional Ethics Committee Jawahar Lal Nehru Medical College
Submittted/Under Review
Institutional Ethics Committee KIMS
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE NHLIEC
Approved
Institutional Ethics Committee PGIMER
Submittted/Under Review
Institutional Ethics Committee Sparsh Hospital
Submittted/Under Review
Institutional Ethics Committee, Ashwin Hospital
Approved
Supe Hospital Ethics Committee
Submittted/Under Review
Visakha Institute Medical Sciences
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Esomeprazole Tablet IP 40 mg
study medication once daily for 4 weeks or 8 weeks
Intervention
Zastaprazan Tablet 20 mg
study medication once daily for 4 weeks or 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 gastroesophageal reflux disease (GERD) and patients must have a Los Angeles
(LA) classification Grade of A to D on the upper gastrointestinal (GI) endoscopy at Screening
3. Patients who have experienced at least two episodes of mild heartburn and/or regurgitation symptom
or one episode of moderate or severe heartburn and/or regurgitation symptom in 7 days prior to
screening
4. 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])
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile
(bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal
woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years
of age]
5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their
female partners should be practicing highly effective contraception throughout the study period.
(Contraception by female partner is not required if she is not a women of childbearing potential).
[No sperm donation is allowed during the study period]
ExclusionCriteria
Details
1. Patients having hypersensitivity or any other contraindication to any of the Investigational products or its components
2. Patients taking any treatment for GERD modifying gastric acid secretion (such as oral antacids,PPIs, P-CABs etc.) within 14 days prior to Randomization
3. Patients with current or past history of:
a) Eosinophilic Esophagitis
b) Gastroesophageal varices, Baretts’s esophagus, active gastric/duodenal ulcer,
gastrointestinal bleeding, or gastrointestinal malignant tumour
c) Zollinger Ellison Syndrome
d) Primary esophageal motility syndrome (e.g., achalasia, Irritable Bowel Syndrome (IBS),
Inflammatory Bowel Disease,
e) Pancreatitis
f) Atrophic gastritis or gastric malignancy or any other GI malignancy
g) Hiatus hernia, Pyloric stenosis, esophageal stricture, esophageal stenosis, a history of
radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to
the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy
or esophageal variceal band ligation),
h) 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 galactose intolerance, Lapp Lactase deficiency or glucose-galactose malabsorption.
6. Patients/ with history of or presence of (Detected on endoscopy) benign gastric polyp or Fundic gland polyp
8. Patients receiving NSAID, Paracetamol, Steroids (except topical), Cholinergic drugs, Antithrombotic drugs (antiplatelet drugs and anticoagulants) within 2 weeks prior to screening.
9. Patients taking high dose methotrexate, bisphosphonate, strong Cytochrome P450 (CYP) 3A4 or CYP3A5 and CYP2C19 inducers or inhibitors within 14 days (or 5 half-lives of particular drug, whichever is longer) prior to screening (screening endoscopy) or required to take during the study
10. 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
11. Patients with history of any clinically significant medical and/or psychological condition or clinically significant laboratory abnormalities that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results
12. Patients having any of the following laboratory abnormalities at screening:
1) Alanine transaminase [ALT] greater than or equal to 2 x upper limit of normal [ULN]
2) Aspartate transaminase [AST] greater than or equal to 2 x ULN
3) Alkaline phosphatase [ALP] greater than or equal to2 x ULN
4) Gamma-glutamyl transferase [GGT] greater than or equal to 2 x ULN
5) Total bilirubingreater than or equal to1.5 x ULN
6) eGFR less-than 70mL/min/1.73m2
13. Patients with history or known cases of osteoporosis who are at increased risk of bone fracture or hypomagnesemia
14. Pregnant and/or lactating female
15. Patient with positive results of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) at screening
16. Patient with history of malignancy in the last 5 years prior to Screening [Note: In case of malignant tumours except digestive malignant tumours, 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]
17. Patient with known alcohol or other substance abuse within one year prior to Screening
18. 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
19. 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 randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Efficacy:
Cumulative proportion of patients with endoscopically confirmed healed EE
Up to Week 8
Secondary Outcome
Outcome
TimePoints
Efficacy:
Proportion of patients with endoscopically confirmed healed EE
Up to Week 4
Change from Baseline in frequency scale for the symptoms of GERD (FSSG) Score
week 4 and week 8
Change from Baseline in the GERD-Health Related Quality of life (GERD-HRQL) questionnaire
week 4 to week 8
Safety:
Proportion of patients with treatment emergent (TEAEs) and serious adverse events (SAEs)
Throughout the study period
Cumulative proportion of patients with endoscopically confirmed healed EE according to LA
grade
Up to Weeks 4 and 8
Proportion of 24 hours heartburn free days
week 4 and week 8
Proportion of 24 hours acid regurgitation free days
week 4 and week 8
Target Sample Size
Total Sample Size="222" Sample Size from India="222" 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)
22/09/2025
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="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel, Double-Blind, Double- Dummy, Phase III study The study will be initiated only after the receipt of regulatory and EC approval.
Screening Period: After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). The screening period will be of maximum 21 days. Patients taking any gastric acid suppression medications. Patients will be provided with enrolment diary to record details about study drug administration, rescue medication, concomitant medication, heartburn events and its severity, regurgitation events and its severity, sleep interference events and adverse events. Patients will be required to bring completed diary at each visit.
Treatment Period: After confirming the eligibility patients will be the randomized patients will take the study medication once daily for 4 weeks or 8 weeks (Treatment period). Patients will be either randomized to Test arm (Zastaprazan 20 mg and placebo o e 40 mg) OR to Comparator arm (Esomeprazole 40 mg or placebo of Zastaprazan 20 mg) Patients will be followed up for efficacy, safety, 10 weeks after the end of treatment. Standard of care will be given to the as per Investigator’s discretion. Patients discontinuing early from the study will be completing Visit 4 (EOT) assessments and EOS assessments will be conducted after 2 weeks of EOT. The efficacy and safety parameters will be assessed during the study period, Patients will be dispensed a visit diary at each visit from randomization to end of treatment to record concomitant medication, any adverse event. Patient will be advised to bring completed diary to the site at each visit.