Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.
研究概览
简要总结
The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with early morning pain and stiffness.
详细描述
Rheumatoid Arhthitis (RA) is a chronic inflammatory condition characterised by prolonged morning stiffness. Anti-inflammatory medication is effective in relieving the pain and stiffness associated with this inflammation. By having a long half-life, Etoricoxib has a simple once daily dosing regime and the long action overnight should mean that patients experience more effective relief of symptoms first thing in the morning compared to shorter half life medication such as Diclofenac. The activity of people can be measured using the NuMact monitor which has been validated against observation and for use in RA . As the data is logged in real time it is possible to extract the periods of activity at the start of the day when morning stiffness will be maximal. It counts the number and vigour of steps.
This can be used to give a measure of total ambulatory activity but in this instance we are interested primarily in the vigour of step first thing in the morning. The vigour of the steps (trunk deceleration on heel strike) is a measure of how easily and quickly a subject is walking. We would expect this to be markedly reduced in people with RA during their period of "morning stiffness".
This is a study is of a randomised crossover design. The aim is to recruit 20 subjects suffering from Rheumatoid Arthritis. 20 has been chosen as a suitable number to show the effects of the two drugs and allow design of a definitive study. All participants will be tolerant of conventional NSAIDs.
All subjects will be given patient information sheets at least 24 hours before the first visit. They will be allowed time to read the information sheet and given the opportunity to ask further questions if they wish during the pre-baseline week.
The first visit is the baseline visit during which informed consent will be taken by the Chief Investigator, all of the inclusion and exclusion criteria will be checked to ensure the subject still meets the criteria. A history of NSAID use will also be taken to ensure subject tolerance of the drug. Quality of life Questionnaires will be administered during this visit, they will consist of the:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 years and over.
- •Subjects who are NSAID tolerant.
- •Subjects with a clinical diagnosis of rheumatoid arthritis.
- •Subjects who are willing to complete QOL questionnaires.
- •Written informed consent
排除标准
- •Co-occurrence of other disabling conditions in addition to rheumatoid arthritis likely to warrant the persistent use of escape analgesia.
- •Subjects who have received an intra-articular or muscular steroid injection within 3 months of study entry or in whom such treatment is planned within the study period.
- •Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period.
- •Severe respiratory impairment.
- •Clinically significant hepatic or renal dysfunction, subjects whose LFTs and serum creatinine is outside normal recognized limits.
- •Subjects with convulsive disorders, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure.
- •Subjects with a known allergy or hypersensitivity to NSAIDs.
- •Subjects with unstable gastro-intestinal complications or disease.
- •Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator's opinion, have previously demonstrated drug-seeking behaviour.
- •Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days.
研究组 & 干预措施
Etoricoxib 90 mg
Subject will take Etoricoxib 90 mg for 14 days
干预措施: Etoricoxib (Drug)
Diclofenac
Film coated tablet 50 mgs given three times a day for 14 days
干预措施: Diclofenac (Drug)
结局指标
主要结局
To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.
时间窗: After 14 days of treatment
Subjects will be asked to complete a visual analogue scale to record pain and stiffness and activity will be recorded with the Numact devise
次要结局
未报告次要终点
研究者
Dr David Walker
Principal Investigator
Northumbria Healthcare NHS Foundation Trust