Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
详细描述
Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.
Study with completed results acquired from Horizon in 2024.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
- •Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303
排除标准
- •Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
- •Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
- •Malignant Disease of the gastrointestinal tract
- •Erosive esophagitis
- •Clinically significant cardiac, renal or hepatic disease
- •Uncontrolled diabetes
- •Positive pregnancy test on Study Day 0
- •Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.
研究组 & 干预措施
HZT-501
HZT-501: ibuprofen 800mg/famotidine 26.6mg
干预措施: HZT-501 (Drug)
Ibuprofen
Ibuprofen 800mg
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: 28 weeks
The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event.
次要结局
未报告次要终点