EUCTR2007-005082-34-GB进行中（未招募）不适用
A Proof of Principle Study to Investigate the Efficacy of aMedical Device and Topical Analgesic Combination for theTreatment of Pain and Performance Related Function inOsteoarthritis - PoP for Device and Analgesic Combination
GlaxoSmithKline Consumer Healthcare0 个研究点开始时间: 2007年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Aged at least 50 years.
- •2)Diagnosis
- •a) Has a radiological diagnosis of OA affecting at least one knee.
- •b) Has symptomatic OA of at least one knee. The symptoms should be significantly worse in one knee than the other if OA affects both knees.
- •c) When questioned at the screening visit, confirm they experience at least mild pain when climbing stairs.
- •d) Able to walk unaided or with the aid of one stick (2 sticks not allowed).
- •3)Contraception
- •Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
- •4)Compliance
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •6)General Health
- •Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history, physical examination or clinical laboratory test.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Pregnancy
- •Women who are pregnant or who have a positive urine pregnancy test.
- •2)Breast-feeding
- •Women who are breast–feeding.
- •3)Medical History
- •a) Suffer from any other condition that would affect their ability to rate pain, complete the exercises or refrain from treatment.
- •b) Are unable to clearly differentiate between symptoms in the joint under investigation compared to the opposite knee.
- •c) Have a history or current evidence of the following secondary causes of OA: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility) or collagen gene mutations.
- •d) Have any specific contraindications to the use of heat patches including inability to feel heat (e.g. neuropathies, circulatory problems) or have damaged skin (scratch, burn, sunburn etc.).
- •e) Have asthma, urticaria, or acute rhinitis which is precipitated by aspirin or other NSAIDs.
- •f) Have any skin conditions (e.g. eczema) that might interfere with the use of the patch for a three day period.
- •g) Have had a knee replacement (in the knee to be treated).
- •4)Medications
- •Patients who have started taking glucosamine supplements within the 6 months prior to the start of the study.
- •5)Allergy/Intolerance
- •Known or suspected intolerance or hypersensitivity to the study materials, washout medication (or closely related compounds) or any of their stated ingredients.
- •6)Clinical Study/Experimental Medication
- •a)Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
- •b)Previous participation in this study.
- •7)Substance abuse
- •Recent history (within the last year) of alcohol or other substance abuse.
- •8)Personnel
- •An employee of the sponsor or the study site or an immediate family member, or resident at the same address as another patient in the study.
研究者
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