CTRI/2024/02/062543已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 30
- 主要终点
- Cumulative proportion of patients with endoscopically confirmed healed EE [Time frame: Upto Week 8]
研究概览
简要总结
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.
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 GERD on the upper GI endoscopy at 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]).
- •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].
排除标准
- •Patients having hypersensitivity or any other contraindication to any of the Investigational product or its component
- •Patients taking any treatment for GERD modifying gastric acid secretion (such as oral antacids, PPIs etc) within 7 days prior to Randomization
- •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.
结局指标
主要结局
Cumulative proportion of patients with endoscopically confirmed healed EE [Time frame: Upto Week 8]
时间窗: Upto Week 8
次要结局
- 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)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (30)
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