EUCTR2007-000078-21-IT进行中（未招募）不适用
?A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo bid and Naproxen 500 mg bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT 3012) 750 mg bid, in Patients with Osteoarthritis of the Hip in Patients with Osteoarthritis of the Hip? - HCT 3012-X-303
ICOX S.A.0 个研究点目标入组 800 人开始时间: 2007年7月25日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for the study, patients must fulfill the following criteria: 1)Men and women >/=40 years old
- •2)Patients must have felt hip pain consistent with OA pain for at least 3 months before the Screening Visit. 3)Patients diagnosed with primary OA of the hip confirmed by the presence of undoubtful osteophyte(s) in the target hip in radiographs . 4)The target joint (hip) must be the patient's primary source of OA pain. 5)Global functional status Class I, II, or III (excluding IV) at the ACR classification. 6)Current chronic user of NSAIDs or acetaminophen/paracetamol for their OA pain and anticipated to benefit from continuous treatment with NSAIDs . 7)Must discontinue all analgesic and/or anti-inflammatory therapies at the Screening Visit except the study specific rescue medication. 8)Must experience a flare of pain at the Baseline Visit, following discontinuation of prior NSAID/analgesic therapy. The flare of pain is defined as: Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC?) question #1 of pain subscale 50 mm, and Increase by 15 mm as compared to the Screening Visit. 9) Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to visit 1 (Screening Visit) and during the study. In addition, female patients must not be lactating. 10) If of childbearing potential, female patients must have a negative urine pregnancy test at both Screening and Baseline Visits. 11) Must be able to understand and comply with study requirements (e.g. attend morning clinic visit). 12) Must provide a written, dated and signed Informed Consent (IC) prior to any study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Uncontrolled hypertension at Screening or Baseline Visits, as judged by the Investigator 2)Uncontrolled diabetes at Screening or Baseline Visits, as judged by the Investigator. 3) Hepatic impairment (alanine aminotransferase or aspartate aminotransferase > 2 times the Upper Limit of Normal) at the Screening blood collection. 4) History of renal impairment and/or a serum creatinine value > 176 mol/L (2.0 mg/dl) at the Screening blood collection. 5) Clinically relevant abnormal electrocardiogram (ECG) (12-lead) at the Screening Visit, as judged by the Investigator. 6) Diagnosis of gastric or duodenal ulceration and/or history of significant gastro duodenal bleeding, within the last 6 months prior to the Screening Visit. 7) History of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or to acetaminophen/paracetamol at the Screening Visit.
研究者
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