A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant pain

Mundipharma Research GmbH & Co.KG0 个研究点目标入组 750 人开始时间: 2004年12月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Males and females at least 18 years of age. (Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.)
•2.Documented history of moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.
•3.Nonmalignant low back pain (for example osteoarthrosis / osteoarthritis of spine, deforming spondylosis, spondylolisthesis, disc herniation / sciatica, spinal stenosis)adequately managed by an opioid analgesic for at least the past 2 weeks.
•4.Subjects who require continuation of daily opioid analgesic treatment and are likely to benefit from chronic opioid therapy (WHO step III opioid) for the duration of the study.
•5.Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Any history of hypersensitivity to oxycodone, naloxone, or related products.
•2.Subjects currently taking the equivalent of <10 mg or >40 mg/d oxycodone. (Refer to Appendix 12.2: Drug Conversion Tables.)
•3.Subjects diagnosed with cancer, not including basal cell carcinoma.
•4.Active alcohol or drug abuse.
•5.Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
•6.Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range).
•7.Surgery completed <= 2 months prior to the start of the Screening Period, planned surgery during the12-week Double-blind Phase, or any other pharmacological or non-pharmacological intervention that would influence pain during the study (not including chemotherapy) or preclude completion of the study.
•8.Subjects presently taking, or who have taken, naloxone or an experimental drug <=30 days prior to the start of the Screening Period.
•9.Subjects with a history of 2 or greater low back surgeries.

发起方

Mundipharma Research GmbH & Co.KG