NCT02788123终止4 期
Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy
研究概览
简要总结
The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.
详细描述
This study has a screening period (up to 3±2 days duration). Randomization will be held in each stratum (H. pylori-positive and H. pylori-negative) on the Visit 1. Treatment period will consist of 2 visits: Visit 2 (up to 14±2 days after Visit 1) in subjects with completely healed ulcer(s) and erosions after control esophagogastroduodenoscopy (EGDS) and Visit 3 (up to 28±2 days after Visit 1) in subjects with not healed ulcers and erosions after control EGDS on Visit 2. The period of follow-up safety assessments will last 1 week after the end of the study treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified diagnosis of NSAID-induced gastropathy:
- •Presence of gastric ulcer(s) and/or erosions (modified Lanza score greater than or equal to 5) based on EGDS findings at screening and;
- •NSAIDs administration within 7 days before screening.
- •Negative pregnancy test at screening and at Visit 1 (for females only using test strip to detect chorionic gonadotropin in urine),
- •Subjects' consent to use a reliable contraception method starting from screening throughout the whole study and for 1 week after its termination.
排除标准
- •Severe complications of NSAID-gastropathy (bleedings, perforations, etc.)
- •The subjects requiring concomitant therapy using the drugs specified in "Forbidden concomitant therapy".
- •Ulcerative esophagitis grade C and higher according to Los-Angeles classification.
- •Expressed hepatic and renal impairment.
- •Any esophageal and gastric surgery that can make subject ineligible for study participation.
- •Abuse of psychoactive substances including alcohol which may interfere with the subject's participation and fulfillment of all the protocol requirements.
- •Participation in other clinical studies within 30 days prior to Screening Visit.
- •Administration of bismuth products less than 2 months prior to screening.
- •Administration of PPIs or histamine Н2-receptor antagonists less than 2 weeks prior to screening.
- •Hypersensitivity to any of the components of the study drugs or contraindications to them.
- •Pregnancy and lactation.
- •Inability to perform follow-up EGDS after 2 and/or 4 weeks of the study.
- •Any condition or concomitant disease and laboratory parameter abnormalities which renders the subject ineligible for the study.
研究组 & 干预措施
bismuth tripotassium dicitrate and pantoprazole
Experimental
Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets
干预措施: bismuth tripotassium dicitrate (Drug)
bismuth tripotassium dicitrate and pantoprazole
Experimental
Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets
干预措施: pantoprazole (Drug)
pantoprazole
Active Comparator
Participants will receive pantoprazole (once daily) as single tablet
干预措施: pantoprazole (Drug)
结局指标
主要结局
Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy
时间窗: Week 2
Modified Lanza score 0-2 (inclusively) shall be considered as healing. The modified Lanza scale is utilized to grade the degree of gastritis
次要结局
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2(Week 2)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 2(Week 2)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 4(Week 4)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 4(Week 4)
- Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group(Baseline, week 2 and week 4)
- Changes in GSRS as compared to visit 1 (baseline) in each treatment group(Baseline, week 2 and week 4)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 2(Week 2)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4(Week 4)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4(Week 4)
- Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group(Baseline, week 2 and week 4)
- Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group(Baseline, week 2 and week 4)
- Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group(Baseline, week 2 and week 4)
- Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group(Baseline, week 2 and week 4)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4(Week 4)
- Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 2(Week 2)
- Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group(Baseline, week 2 and week 4)
- Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group(Baseline, week 2 and week 4)
- Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group(Baseline, week 2 and week 4)
- Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group(Baseline, week 2 and week 4)
- Safety assessed through esophagogastroduodenoscopy(Up to day 35)
- Number of participants with laboratory value abnormalities and/or adverse events related to treatment(Up to day 35)
- Safety assessed by nature, frequency and severity of Adverse Events (AEs)(Up to day 35)
- Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs)(Up to day 35)
- Number of participants with Physical Exam abnormalities and/or adverse events related to treatment(Up to day 35)
- Number of participants with vital signs abnormalities and/or adverse events related to treatment(Up to day 35)
研究者
研究点 (5)
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