A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 565
- 主要终点
- Patient Global Rating of Pain for the Study Period (12 Weeks)
研究概览
简要总结
The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females between the ages of 40-75 with a diagnosis of moderate to severe osteoarthritis of the knee, consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee:
- •Current knee pain
- •Less than 30 minutes of morning stiffness with or without crepitus on active motion.
- •Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study.
- •C-reactive protein (CRP) < 8 ug/ml (if available at local lab) or erythrocyte sedimentation rate (ESR) < 40 mm/hr
- •Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of > 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
- •Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- •Research Ethics Board (REB) approval of the written Informed Consent Form in Spanish or English which was signed and dated by the patient and Investigator, prior to study participation.
排除标准
- •Known rheumatoid arthritis or any other rheumatoid disease.
- •Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; osteochondromatosis; or collagen gene mutations.
- •Evidence of effusion greater than 15 cubic centimetre (cc) upon physical examination of the joint at Baseline (Visit 1).
- •Body Mass Index (BMI) ≥
- •Major illness, requiring hospitalization during the 3 months before commencement of the screening period.
- •The patient was unwilling to stop taking pain medication (for arthritis or other types of pain) or was unwilling to stop taking other medications for the treatment of osteoarthritis (OA).
- •Previous failure or discontinuation (due to adverse events) of tramadol hydrochloride (HCl) therapy.
- •Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or any other drug that reduces seizure threshold.
- •Treatment with another investigational agent within the last 30 days.
- •A history of seizure disorder other than Infantile Febrile Seizures.
- •Previous or current opioid dependency.
- •Bowel disease causing malabsorption.
- •Pregnancy or lactating or childbearing potential and unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
- •Significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
- •Significant renal disease, defined as creatinine clearance <30 mL/min as estimated by the method of Levey et al.,
- •Current substance abuse or dependence, other than nicotine.
- •Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
- •Any other condition, that, in the opinion of the Investigators, would have adversely affected the patient's ability to complete the study or its measures.
研究组 & 干预措施
4: Placebo
干预措施: Placebo (Drug)
1 Tramadol Once A Day 100mg
干预措施: Tramadol Once A Day (Drug)
2: Tramadol Once A Day 200mg
干预措施: Tramadol Once A Day (Drug)
3: Tramadol Once A Day 300mg
干预措施: Tramadol Once A Day (Drug)
结局指标
主要结局
Patient Global Rating of Pain for the Study Period (12 Weeks)
时间窗: 12 weeks
3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer.
Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)
时间窗: Baseline to week 12
Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
时间窗: Baseline to week 12
Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.
次要结局
- Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)(Week 0, week 3, week 6)
- Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)(Week 0, week 3, week 6)
- Multiple Dose Effect Using 24-hour VAS Pain Questionnaire(12 weeks)
- Investigator Global Rating of Pain Relief(12 weeks)
- Percentage of Participants Who Dropped Out From Trial by Dropout Reason(12 weeks)