EUCTR2004-004885-33-BE进行中（未招募）不适用
Topical treatment of hand osteoarthritis with glucosamine cream.
Bio Minerals n.v.0 个研究点开始时间: 2008年6月24日最近更新:
适应症
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
- •- Patients of either sex
- •- Age > 30 years
- •- Providing of written informed consent.
- •- Patients with hand osteoarthritis according to the diagnostic criteria of the American College of Rheumatology
- •- Patients with primary (non-erosive and erosive OA) and post-traumatic (due only to remote [> 6 months ago] trauma).
- •- Patients with thumb OA
- •- On entry, a global hand pain score in the target hand of at least 40 mm on a 100 mm visual analogue scale (VAS), after withdrawal of other analgesic/anti-inflammatory medications.
- •- Patients who are taking paracetamol (as rescue medication) are allowed to participate in the trial.
- •- Minimum symptom duration: pain should have been present for at least half of the days in the previous month (i.e. pain should have been present for at least 15 days in the previous month) and for at least 48 hours prior to inclusion visit (T0).
- •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
- •- Patient unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols.
- •- Unlikely to co-operate fully in the study.
- •- Alcohol (e.g. more than 28 units per week) or drug abuse.
- •- Pregnancy or breastfeeding women.
- •- Patients with a swollen or warm joint thought to be secondary to gout, pseudogout or sepsis.
- •- Clinically significant medical abnormalities, which would make the patient unsuitable for the study as judged by the investigator.
- •- The patient has a fracture or malignant tumor at the hands. Significant injury to the affected joint within 6 months of trial start. Disease upper extremity joints of sufficient degree to affect assessment of the target joint. Presence of OA secondary to known disorders other that remote (> 6 months ago) trauma.
- •- Poor general health interfering with compliance or assessment
- •- Less than 1 month between the time of IA injection of depocorticosteroid and enrollment.
- •- Less than 6 months between the time of IA injection of a hyaluronate and enrollment.
- •- Patients with symptomatic knee OA.
- •- Use of assistive devices such as a cane or crutch.
- •- Less than 3 months between the treatment with a slow acting drug for symptom relief and enrollment
- •- Concomitant and previous medication:
- •? Use (topical, systemic, intra-articular) of hyaluronic acid, glucosamine sulphate, glucosamine HCl, n-acetyl glucosamine and derivatives thereof such as chondroitin sulphate, glycosaminoglycans.
- •? Patients who have used previous topical and/or systemic treatment with NSAID’s or analgetica, different from paracetamol, such as ibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study
- •? Patients who have used medications with MMP-inhibitory properties (e.g. tetracyclines or structurally related compounds), or took oral (systemic, > 10 days duration) glucocorticoids in a 28 days period prior to start of the study.
- •? Patients who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein, glucosamine and/or chondroitin sulfate containing compounds) in a 28 days period prior to start of the study.
- •- Treatment during the trial with physical and/or occupational therapy.
- •- Known allergy against glucosamine or any of the ingredients in the cream.
- •- Open wounds at the hands.
研究者
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