A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 627
- 主要终点
- Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
研究概览
简要总结
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
详细描述
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.
Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
- •Did not use a NSAID within the 30 days prior to study entry
排除标准
- •History of erosive esophagitis
- •History of any of the following serious gastrointestinal complications:
- •perforation of ulcers,
- •gastric outlet obstruction due to ulcers,
- •gastrointestinal bleeding.
- •Active cardiac, renal, and/or hepatic disease
- •Current Helicobacter pylori (H. pylori) infection
- •Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Positive pregnancy test at screening
- •Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Currently participating, or participation within 30 days prior to study entry, in an investigational drug study
- •Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
研究组 & 干预措施
1
HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
干预措施: HZT-501 (Drug)
2
Ibuprofen 800mg
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
时间窗: 24 weeks
The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
次要结局
- Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.(24 weeks)
- Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.(24 weeks)
- The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.(24 weeks)