CTRI/2010/091/001041未知3 期
A MULTICENTRIC, OPEN-LABEL, ANALYST-BLIND, RANDOMIZED, PARALLEL-GROUP, TRAMADOL-CONTROLLED, PHASE-III CLINICAL TRIAL TO ASSESS THE EFFICACY, TOLERABILITY, AND SAFETY OF TAPENTADOL TABLETS IN PATIENTS OF OSTEOARTHRITIS & POST-OPERATIVE PAIN AFTER ORTHOPEDIC SURGERY?
M/s. MSN Laboratories Ltd., Hyderabad4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The primary efficacy outcome for this study is the evaluation of pain done on twice daily basis by the patient himself using 11-point NRS scale, where 0 is no pain and 10 is worst possible pain experienced. The investigator will perform this test on day 0 i.e. day of randomization, day 5 i.e. day of interim analysis and day 10, which is the end of the study period.2] Pain intensity difference (PID) This will be used to examine the change in pain intensity from baseline and will be calculated as baseline pain intensity - current pain intensity, with the mean pain intensity from the 3 days of pain intensity measurements before randomization used as the baseline value. Sum of PID over the first 5 days (5-day SPID), the primary efficacy end point, will be calculated as ΣPID (time elapsed since the previous observation), with the sum including all observations of PID collected from the evening of day 1 to the evening of day 5. Two-day SPID and 10-day SPID will be calculated in a similar manner.
研究概览
简要总结
This study is a randomized, open label, parallel group, multi centre trail comparing the safety and efficacy of Tapentadol in patients with Osteoarthritis & Post-Operative Pain after Orthopedic Surgery for 5 months in 200 patients will be conducted in four centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •■All patients with duly filled and signed in ICFs [Informed Consent Forms] ■Ages: > 18 years and < 80 years ■Genders Eligible for Study: both ■Patients who are candidates for orthopedic surgery.
- •■Patients requiring daily doses of analgesics, consistent with treatment at step II or higher of the World Health Organization pain relief ladder.
- •■In addition, eligible patients has to report a mean pain intensity score > 5 on an II-point numerical rating scale (NRS) over 3 days of pain measurements completed before randomized assignment to treatment groups.■Women of childbearing age using accepted mode of birth control.
排除标准
- •■The exclusion criteria are based on precautions related to centrally acting analgesics and the standard conduct of clinical trials.
- •■Patients unwilling to sign on ICF■Patients with a history of chronic hepatitis B or C infection, HIV infection, ■Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse.
- •■Patients with suspected or apparent seizure disorders, concomitant autoimmune inflammatory conditions involving the target joint, acute crystal-induced arthropathy (within 6 months before screening), moderate to severe renal insufficiency, or hepatic impairment.
- •■Patients will also be excluded if they have received systemic steroid therapy within 4 weeks before screening, IR opioids for >4 days per week within 28 days of the screening period, or extended-release opioids within 28 days of the screening period.
- •■Patients who have received an experimental drug or used an experimental device within 28 days of study entry will be excluded from participation, as will be patients with a history of sensitivity to Tapentadol, hydromorphone, morphine, fentanyl, or their excipients.
- •■Patients who had previously participated in studies of Tapentadol will also be excluded.■Pregnant or lactating patients■Patients having abnormal liver parameters such high values of AST, ALT and ALP, ■Patients having received other investigational medication within the last 3 months, or having participated in the trial.
结局指标
主要结局
The primary efficacy outcome for this study is the evaluation of pain done on twice daily basis by the patient himself using 11-point NRS scale, where 0 is no pain and 10 is worst possible pain experienced. The investigator will perform this test on day 0 i.e. day of randomization, day 5 i.e. day of interim analysis and day 10, which is the end of the study period.2] Pain intensity difference (PID) This will be used to examine the change in pain intensity from baseline and will be calculated as baseline pain intensity - current pain intensity, with the mean pain intensity from the 3 days of pain intensity measurements before randomization used as the baseline value. Sum of PID over the first 5 days (5-day SPID), the primary efficacy end point, will be calculated as ΣPID (time elapsed since the previous observation), with the sum including all observations of PID collected from the evening of day 1 to the evening of day 5. Two-day SPID and 10-day SPID will be calculated in a similar manner.
时间窗: 10 day
次要结局
- Secondary outcomes include the effect of Tapentadol IR on the basis of Patient Global Impression of Change (PGIC) at the baseline, day 5 and day 10, which is the end point of the trial. PGIC will be assessed, wherein patients will indicate their response to the statement "Since I began study medication, my overall status is ..." using a scale from 1 =very much improved to 7 =very much worse.(10 day)
研究者
研究点 (4)
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