Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs: Application of Pharmacotherapeutic Conditioning in Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in level of pain
研究概览
简要总结
The following study investigates the role of information/expectancies in the response to Ibumetin and placebo.
The study is a double-blind randomized controlled trial with crossover, within subjects repeated measurements. The symptoms are measured by questionnaires. 40 patients will be included in the study. The administrated drug is Ibumetin 400 mg.
The study does not require patients to meet in the clinic. Patients will be instructed in how to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim, Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the patients will receive a sms where they are instructed to immediately rate their pain and stress level and report back.
详细描述
The study is a double-blind randomized controlled trial with crossover, within subjects repeated measurements. The symptoms are measured by questionnaires. 40 patients will be included in the study. Patients are recruited via the Department of Rheumatology, UNN. The patient group is selected because they respond well to NSAIDs. Since the patients can participate while being at home it is not a requirement to live in Tromsø.
When the patients are recruited their normal treatment plan is examined. This includes both their prescript treatment from the patient's physicians and also non-prescript substances, such as herbal medicine. If these drugs or substances inflict with the study treatment plan, the patients will be excluded. The patient will follow the study treatment plan on study days only, which is three days during the week. During the study days the patients will be required to abstain from any other substances that can influence the treatment, such as alcohol, both prescription and nonprescription drugs and herbal medicine. After 19:00 the study day is over and other medication can be taken. On the non-study days the patients can follow their normal treatment plan, but if the following day is a study day, no medication can be consumed after 21:00.
The patients can at any time withdraw from the study. A patient who withdraws from the study will not be replaced.
Data collection
The study does not require patients to meet in the clinic. The patients can be at home, at work or performing their daily routines as they participate. Information about the procedures of self-administration will either be given to the patients in written form through mail or in person by the experimenter. Patients will be instructed in how to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim, Norway). Data from the sms is automatically saved in a database administrated by Checkware AS and the research team. The patient's phone number is connected to a patient ID number in the database. The patients name is connected to the same identification number in a different document safely secured on a different hard disk.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have been diagnosed with radiographic Axial Spondyloarthritis, also called Ankylosing Spondylitis, OR
- •Patients must have been diagnosed with non-radiographic Axial Spondyloarthritis with a positive magnetic resonance (MR).
- •Patients must have been successfully treated with NSAIDs for at least three months
- •Patients must be above 20 years old
- •Patients must satisfy the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg
- •All patients must sign a consent form describing that they will receive placebo during the study period. The Informed Consent Form and The Data Release Form must be signed before inclusion in the studies.
排除标准
- •Patients cannot participate in other clinical studies parallel to the current study. Previous study participations must be completed more than one year, prior to participating in the current study.
- •Patients not satisfying the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg:
- •Patients who previously have experienced allergic reactions to NSAIDs
- •Patients with previous or currant ulcers and/or gastrointestinal conditions - or bleeding
- •Patients with previous or currant cardiovascular conditions, or have experienced cardiovascular episodes
- •Patients with previous or currant renal failure
- •Patients with acetaminophen - or NSAID-induced asthma, urticarial or rhinitic
- •Patients with previous or current other serious conditions apart from rheumatoid arthritis
- •Female patients trying to or having trouble getting pregnant cannot participate in the study
- •Pregnant and/or nursing patients cannot participate in the study
- •Patients on a treatment plan with Prednisolon
- •Patients on a treatment plan with substances inflicting with Ibumetin. All substances will be investigated on www.interaksjoner.no
研究组 & 干预措施
Ibuprofen/Ibumetin
Ibumetin is administrated. Intervention: No information about the effect.
干预措施: Ibuprofen (Drug)
Placebo
Placebo is administrated. Intervention: No information about the effect.
干预措施: Placebo (Drug)
Ibuprofen/Ibumetin+positive information
Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.
干预措施: Ibuprofen (Drug)
Placebo+positive information
Placebo is administrated. Intervention:The patient receive written information that the capsule is Ibumetin.
干预措施: Placebo (Drug)
Ibuprofen/Ibumetin+neutral information
Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.
干预措施: Ibuprofen (Drug)
Placebo+neutral information
Placebo is administrated. Intervention:The patients receive information that the capsule is placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in level of pain
时间窗: up to 12 weeks
次要结局
- Change in level of stress and nervousness(up to 12 weeks)