6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 主要终点
- Number of Participants With Gastric Ulcer Confirmed by Endoscopy
研究概览
简要总结
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.
详细描述
Objectives:
Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.
Secondary:
- To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
- To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
- To compare heartburn symptoms in subjects treated with PN400 versus naproxen
- To evaluate the safety and tolerability of PN400 and naproxen
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PN400
Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily
干预措施: PN400 (VIMOVO) (Drug)
Naproxen
Naproxen 500 mg dosed twice daily
干预措施: Naproxen (Drug)
结局指标
主要结局
Number of Participants With Gastric Ulcer Confirmed by Endoscopy
时间窗: 6 months
The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.
次要结局
- The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer(6 Months)
- The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment(6 months)
- Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit(6 months)
- Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire(change from baseline at 6 Months)
- The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers(6 months)
- Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales(Baseline to 6 Months)
- Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales(baseline to 6 Months)
- Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales(baseline to 6 Months)