Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand: a 6-month, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 163
- 主要终点
- Change in Global Spontaneous Pain Intensity of Target Hand
研究概览
简要总结
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
详细描述
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients.
Primary endpoints:
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Secondary endpoints are:
Efficacy evaluation: Global impression of efficacy expressed by the patient and the physician (VAS), Grip strength (measured manometrically); Morning stiffness duration; Consumption of Paracetamol; Tolerability (4-point verbal scale); Adverse Events occurring during the treatment period; Other parameters:Treatment compliance; Biological markers of arthritis
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex
- •Aged 40 and over
- •Outpatients
- •Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
- •Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (< 6 month).
- •Suffering from regular spontaneous pain on the dominant hand (VAS > or = 40 mm at inclusion time).
- •Showing a FIHOA score > or =
- •Having had at least two painful flares in a finger joint during the previous 12 month.
- •Patients who have signed the written informed consent for their participation in the study
- •Patients able to understand and follow the protocol.
- •Patients with a satisfying health and nutritional status.
- •Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
- •Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.
排除标准
- •Inflammatory joint disease of other origin
- •Septic arthritis
- •Chronic inflammatory joint disease
- •Previous articular fracture of the concerned articulations
- •Use of analgesic therapy for other indications
- •Receiving oral corticosteroids
- •Mono-articular posttraumatic OA of the finger
- •Planning surgery of the hands in the following 6 months
- •Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:
- •Infectious arthritis - Acromegaly
- •Ochronosis - Hemachromatosis
- •Gout - Wilson's disease
- •Chondrocalcinosis - Paget's disease
- •Osteochondrosis - Mutation of collagen
- •Genetic problems (for ex. hypermobility) - Previous joint fracture
- •Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
- •Congenital abnormalities
- •Recurrent pseudogout
- •Major dysplasias
- •Intra-articular injection in a hand joint from less than 3 months
- •Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months
- •Articular lavage in the last 3 months
- •Treatment with corticoids, by any administration route during the last month
- •Patient suffering from frequent asthma crises
- •Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
- •Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
- •Participation in other clinical trials in the two months preceding the study
- •Known or ascertained hypersensitivity to the active ingredient of the tested drug.
- •Patients refusing to sign the written informed consent form
- •Patients who do not co-operate, not respecting the protocol requirements
- •Pregnant or lactating women
研究组 & 干预措施
Chondroitin 4&6 sulfate (Condrosulf)
干预措施: Chondroitin 4&6 sulfate (Condrosulf) (Drug)
placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Global Spontaneous Pain Intensity of Target Hand
时间窗: 6 months
Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand.
Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand
时间窗: 6 month
Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score. Change calculated as difference between the month 6 value and baseline value Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand
次要结局
- Consumption of Paracetamol(6 months)
- Investigator Global Evaluation on Efficacy(6 months)
- Change in Grip Strength(6 months)
- Change in Morning Stiffness Duration(6 months)