NCT00950651已完成3 期
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 431
- 主要终点
- Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
研究概览
简要总结
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.
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 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- •Knee pain at study enrolment,
- •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 1 year prior to entry into the study.
- •ESR < 40 mm/h
- •Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 150 mm at baseline.
- •Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- •The Patient signed and dated the (IEC) approved, written, informed consent 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; heritable arthritic disorders; or collagen gene mutations.
- •Obesity Class II [body mass index (BMI) equal to or more than 35 kg/m2] (NIH, 2000)
- •Major illness that required hospitalisation during the 3 months before commencement of the screening period.
- •Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
- •Patients who had previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to AEs.
- •Patients who within the 3 weeks prior to study entry took the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
- •Patients who took another investigational agent within the 30 days prior to study entry.
- •Patients with a history of seizure disorder other than Infantile Febrile Seizures.
- •Patients who were opioid dependent.
- •Patients with bowel disease causing malabsorption.
- •Patients who were pregnant or lactating or patients of child-bearing potential who were unwilling to utilise a medically approved method of contraception during participation in this clinical trial.
- •Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
- •Patients with 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, adversely affected the patient's ability to complete the study or its measures.
研究组 & 干预措施
1 Tramadol HCl Contramid® Once A Day
Experimental
干预措施: Tramadol HCl Contramid® Once A Day (Drug)
2 Tramadol HCl Twice a day (SR)
Active Comparator
干预措施: Tramadol HCl Twice a day (Drug)
结局指标
主要结局
Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
时间窗: Baseline to week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
次要结局
- Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)(12 weeks)
- Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in WOMAC Total Score at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in Current Pain at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12(Baseline to week 12)
- Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12(Baseline to week 12)
- Patient Global Rating of Pain Relief at Week 12(12 Weeks)
- Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12(12 weeks)
- Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12(12 weeks)
- Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12(12 weeks)
- Physician Overall Rating: Overall Assessment at Week 12(12 weeks)
- Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12(12 weeks)
- Patient Diary: Pain (Between Visit Means) at Week 12(12 weeks)
- Patient Diary: Stiffness (Between Visit Means) at Week 12(12 weeks)
- Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12(12 weeks)
- Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12(12 weeks)
- Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12(12 weeks)
研究者
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