National, Multicentre, Observational, Non-Interventional Prospective Study of Dexlansoprazole MR in GERD Patients in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Month 1 (Visit 3)
研究概览
简要总结
The primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation.
详细描述
This is an observational, prospective non-interventional study of participants with GERD. This study will evaluate the effect of dexlansoprazole treatment among participants with GERD.
The study will enroll approximately 1500 participants. Due to non-interventional design of the study, the decision about GERD treatment strategy for the participant is taken by attending treating physician. All participants will be enrolled in one observational group: dexlansoprazole.
Prospective data will be collected for a period of 2 months. The frequency of the visits will be assigned by each physician according to their routine practice.
The multi-center trial will be conducted in Russia. The overall duration of study will be approximately 2 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants 18 or older years of age by the time of enrolment.
- •Confirmed GERD diagnosis (Non-Erosive Reflux Disease (NERD) or Erosive Reflux Diseases (ERD)) on the base of typical clinical features (symptoms), upper endoscopy within last 12 months prior to inclusion and/or GERDq.
- •Participants diagnosed with GERD less than (<) 3 years prior to study entry, with or without treatment with other GERD medications.
- •Participants without concomitant gastrointestinal (GI) conditions of the gastrointestinal tract and with concomitant GI conditions of the gastrointestinal tract as well as other organ systems concomitant conditions.
- •The physician decides to prescribe Dexilant:
- •as monotherapy or
- •as a part of combined therapy
- •Written informed consent, signed before the participation in the study begins.
排除标准
- •Contraindications for proton-pump inhibitors (PPIs) of respective approved local packaging leaflets.
- •Existence of upper gastrointestinal bleeding.
- •History of surgery on esophagus, stomach or duodenum.
- •Primary esophageal motility disease, achalasia, scleroderma, esophageal / pyloric stricture, primary esophageal spasm, infectious or inflammatory bowel disease, severe malabsorption, severe chronic heart failure, serve cardiovascular disease, renal failure, chronic obstructive pulmonary disease (COPD), asthma, liver cirrhosis.
- •Malignant disease of any kind any system or organ within 5 years, except completely recovered skin cancer.
- •Needs in antibiotics due to severe infection.
- •Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >=Upper limit of normal range*
- •Current, previous (within the last one year) or planned (for the next one year) participation in interventional clinical trial.
- •Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Any other condition, which on the opinion of the investigator may interfere the participant's participation in the study.
结局指标
主要结局
Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Month 1 (Visit 3)
时间窗: Baseline (Visit 1), Month 1 (Visit 3)
GERDq is a self-completed participant questionnaire that is used to assess the frequency of following symptoms: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GERDq score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GERDq greater than or equal to (\>=)8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points=0 percent (%) likelihood of GERD; 3 to 7 points=50% likelihood of GERD; 8 to 10 points=79% likelihood of GERD; 11 to 18 points=89% likelihood of GERD.
次要结局
- Change From Baseline (Visit 1) in Each of the 6 Questions in GERDq on Dexilant Treatment Among the GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)(Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4))
- Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)(Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4))
- Changes From Baseline (Visit 1) in Daytime Severity GERD Symptoms by Likert Scale on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)(Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4))
- Changes From Baseline (Visit 1) in Nocturnal Severity GERD Symptoms by Likert Scale on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)(Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4))