Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Zastaprazan Tablet 20 mg: study medication once daily for 4 weeks or 8 weeks
Control Intervention1: Esomeprazole Tablet IP 40 mg: study medication once daily for 4 weeks or 8 weeks
Sponsors
Sun Pharma Laboratories Limited. (SPLL)
Sun Pharmaceutical Industries Limited SPIL
Eligibility
Inclusion criteria
Inclusion criteria: 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]
Exclusion criteria
Exclusion criteria: 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 ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Cumulative proportion of patients with endoscopically confirmed healed EE Timepoint: Up to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of patients with endoscopically confirmed healed EETimepoint: Up to Week 4;Change from Baseline in frequency scale for the symptoms of GERD (FSSG) Score Timepoint: week 4 and week 8 ;Change from Baseline in the GERD-Health Related Quality of life (GERD-HRQL) questionnaire Timepoint: week 4 to week 8 ;Safety: Proportion of patients with treatment emergent (TEAEs) and serious adverse events (SAEs) Timepoint: Throughout the study period;Cumulative proportion of patients with endoscopically confirmed healed EE according to LA gradeTimepoint: Up to Weeks 4 and 8 ;Proportion of 24 hours heartburn free daysTimepoint: week 4 and week 8;Proportion of 24 hours acid regurgitation free daysTimepoint: week 4 and week 8 | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed