Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 506
- 主要终点
- Change From Baseline in Reflux Disease Symptom - Heartburn
研究概览
简要总结
The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.
详细描述
Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.
This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Had Gastro Esophageal Reflux disease with or without oesophagitis.
- •Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.
排除标准
- •History of surgery of stomach or oesophagus.
- •Gastric ulcer (can be included after healing of gastric ulcer).
- •Duodenal ulcer (can be included after healing of duodenal ulcer).
- •Bleeding (melena, hematemesis).
- •Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
- •Barrett oesophagus with dysplasia.
- •Complicated esophagitis (oesophageal strictures or ulcers).
- •Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
- •Pregnancy, wish to become pregnant, breast feeding.
- •Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) > 100 mg/day.
研究组 & 干预措施
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Change From Baseline in Reflux Disease Symptom - Heartburn
时间窗: Baseline and Week 8
Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation
时间窗: Baseline and Week 8
Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing
时间窗: Baseline and Week 8
Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen
时间窗: Baseline and Week 8
Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting
时间窗: Baseline and Week 8
Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat
时间窗: Baseline and Week 8
Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy
时间窗: Baseline and Week 8
Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks \>5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are \<75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).
次要结局
- Change From Baseline in Enterochromaffin-like Cell Hyperplasia(Baseline and Year 5)
- Change From Baseline in Antrum Atrophy(Baseline and Year 5)
- Change From Baseline in Corpus Atrophy(Baseline and Year 5)
- Change From Baseline in Average Antrum Chronic Inflammation Score(Baseline and Year 5)
- Change From Baseline in Corpus Chronic Inflammation Score(Baseline and Year 5)
- Change From Baseline in Antrum Intestinal Metaplasia(Baseline and Year 5)
- Change From Baseline in Corpus Intestinal Metaplasia(Baseline and Year 5)
- Change From Baseline in Blood Analysis - Testosterone(Baseline and Year 5)
- Change From Baseline in Blood Analysis - Luteinizing Hormone(Baseline and Year 5)
- Change From Baseline in Blood Analysis - Follicle Stimulating Hormone(Baseline and Year 5.)
- Ophthalmologic Examination - Visual Acuity(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Adaptation With Glare(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Accommodation(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Color Vision(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye(Baseline and Year 5)
- Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye(Baseline and Year 5)