NCT00484120已完成2 期
Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis
Pharmos4 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Analgesic activity as measured by the WOMAC pain subscale.
研究概览
简要总结
This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.
详细描述
This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 50 years of age and above.
- •Patients with primary osteoarthritis in at least a single knee joint, grade 2 or 3 based on the Kellgren and Lawrence classification system.
- •Radiographic evidence consistent with OA carried out within the 6 months before screening.
- •Pain should have been present for at least half of the days in the previous month and for at least 48h prior to the screening visit.
- •Eligible subjects must have used an oral, topical or rectal NSAID within the past 6 months before screening.
- •At baseline, after a 1 week withdrawal period of analgesic/anti-inflammatory medications, subjects should have a flare of pain.
- •Able to read, comprehend, and sign the consent form.
- •Examined by the authorized physician and medically cleared to participate in the study.
- •In general good health and have no contraindications to any of the investigational medicinal products.
排除标准
- •Secondary osteoarthritis.
- •Presence of a serious or unstable medical condition (e.g., malignancy, severe neurological impairment or uncontrolled hypertension) or poor general health interfering with compliance or assessment at the study physician's discretion.
- •OA causing significant pain in any joint other than the knees.
- •Any other rheumatic or non-rheumatic joint disease or any other painful condition within the past month (e.g. fibromyalgia).
- •Knee surgery or other knee trauma at any time during the previous year or subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery etc.).
- •Active or history of gastrointestinal ulceration or bleeding within the past 5 years.
- •Presence of a significant active psychiatric disorder including major depression or subjects receiving anti-psychotic medication.
- •Existence of any dermatological condition on the knee.
- •Subjects with disabling congestive heart failure (CHF), angina, pulmonary disease.
- •Clinically significant abnormal blood results.
- •Subjects cannot have had an arthrocentesis prior or during the study.
- •Concomitant treatment with physical and/or occupational therapy.
- •Prior use of any type of NSAID or other analgesic before taking the first dose of investigational medicinal product. Rescue treatment will be allowed during the study
- •Change in sedative or CNS/psychotropic agent within the past month.
- •Chronic treatment with anticoagulants (e.g. Warfarin).
- •Subjects under treatment with corticosteroids.
- •Subjects using topical analgesics including OTC products.
- •Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test.
- •Active alcoholism or substance abuse.
- •Has taken an investigational drug or has used an investigational device within the past 30 days.
- •History of hypersensitivity and/or idiosyncrasy to diclofenac or excipients employed in this study, aspirin or other NSAIDS.
- •Has previously been entered into this study.
- •Any condition that in the investigator's judgement precludes participation in the study.
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo cream (Drug)
1
Experimental
3% Diclofenac NE cream
干预措施: 3%-Diclofenac-Nano-Emulsion Cream (Drug)
结局指标
主要结局
Analgesic activity as measured by the WOMAC pain subscale.
时间窗: 1 month
次要结局
- Patient's daily pain assessment in the home diary.(1 month)
- Pain on walking.(1 month)
- Safety and Tolerability.(1 month)
研究者
研究点 (4)
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