CTRI/2025/09/094603尚未招募3 期
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
Sun Pharma Laboratories Limited. (SPLL)13 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2025年9月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 试验地点
- 13
- 主要终点
- Efficacy:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent
- •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
- •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
- •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]
- •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].
排除标准
- •Patients having hypersensitivity or any other contraindication to any of the Investigational products or its components
- •Patients taking any treatment for GERD modifying gastric acid secretion (such as oral antacids,PPIs, P-CABs etc.) within 14 days prior to Randomization
- •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
- •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
- •Patients with history of galactose intolerance, Lapp Lactase deficiency or glucose-galactose malabsorption.
- •Patients/ with history of or presence of (Detected on endoscopy) benign gastric polyp or Fundic gland polyp
- •Patients receiving NSAID, Paracetamol, Steroids (except topical), Cholinergic drugs, Antithrombotic drugs (antiplatelet drugs and anticoagulants) within 2 weeks prior to screening.
- •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
- •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
- •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
- •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
- •Patients with history or known cases of osteoporosis who are at increased risk of bone fracture or hypomagnesemia
- •Pregnant and/or lactating female
- •Patient with positive results of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) at screening
- •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]
- •Patient with known alcohol or other substance abuse within one year prior to Screening
- •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
- •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.
结局指标
主要结局
Efficacy:
时间窗: Up to Week 8
Cumulative proportion of patients with endoscopically confirmed healed EE
时间窗: Up to Week 8
次要结局
- Efficacy:(Proportion of patients with endoscopically confirmed healed EE)
- Change from Baseline in frequency scale for the symptoms of GERD (FSSG) Score
- Change from Baseline in the GERD-Health Related Quality of life (GERD-HRQL) questionnaire
- Safety:(Proportion of patients with treatment emergent (TEAEs) and serious adverse events (SAEs))
- Cumulative proportion of patients with endoscopically confirmed healed EE according to LA(grade)
- 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)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (13)
Loading locations...
相似试验
尚未招募
3 期
A clinical study to see the effect and safety of Fixed Dose Combination of Silodosin and Solifenacin Capsules in Comparison to Silodosin Capsules in Male Patients Having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) with Over Active Bladder (OAB)CTRI/2020/07/026419Sun Pharma Laboratories Limited266
尚未招募
3 期
A Clinical study of Fixed Dose Combination of Bilastine 10 mg plus Montelukast 4 mg orodispersible Tablets compared with Bilastine 10 mg orodispersible Tablet and Montelukast 4 mg orodispersible Tablet monotherapy for the Treatment of Allergic Rhinitis.CTRI/2022/03/040760Akums Drugs Pharmaceuticals Limited
已完成
3 期
Fixed dose combination of Azilsartan medoxomil and Chlorthalidone for tratment of hypertensioCTRI/2017/12/010961SYNOKEM Pharmaceuticals Limited306
招募中
3 期
A multiple centre Phase III study of Azelnidipine in Newly Diagnosed Patients with Mild to Moderate Hypertension.CTRI/2015/08/006136Precise Chemipharma Pvt Ltd600
进行中（未招募）
不适用
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV MelanomaStage III (Unresectable) or IV MelanomaEUCTR2005-006082-14-DEBristol-Myers Squibb International Corporation500