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 PainEstudio aleatorizado, doblemente enmascarado, con Contro Placebo y Activo, de grupos paralelos, para determinar la eficacia y seguridad de Oxicodona/Naloxona comprimidos de liberación prolongada en sujetos con dolor no maligno crónico moderado a severo - OXN in moderate to severe, chronic nonmalignant pai
- Conditions
- Moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.MedDRA version: 7.0Level: ptClassification code 10003988
- Registration Number
- EUCTR2004-003752-19-ES
- Lead Sponsor
- Mundipharma Research GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method