Moderate to severe chronic pain of low back that requires around-the-clock opioid therapy. MedDRA version: 7.0 Level: pt Classification code 10003988
Conditions
Interventions
Trade Name: OXN 10/5mg Retardtabletten
Product Name: OXN 10/5 mg Retardtabletten
Product Code: OXN 10/5
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS
Sponsors
Mundipharma Research GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1.Any history of hypersensitivity to oxycodone, naloxone, or related products. 2.Subjects currently taking the equivalent of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.;Secondary Objective: •To determine sleep quality during treatment with OXN compared with placebo and OXY compared with placebo as measured by the sleep interference item of the Brief Pain Inventory Short Form (BPI-SF)5. •To determine the total amount of rescue medication used per day (24 hours) by subjects receiving OXN, OXY, and placebo. •To determine subjects’ global (12-week/early discontinuation) satisfaction with the study medication during the Double-blind Phase using the Patient Global Impression of Change scale (PGIC). ;Primary end point(s): Pain Event. A pain event is demonstrated by unacceptable pain control for 2 consecutive days. Each pain event is 2 discrete days, eg, there can be a maximum of 2 pain events in 4 days. A day of unacceptable pain control is defined as: 1) Pain Intensity Scale (“Average Pain over 24 Hours”) score = 5 or 2) Pain Intensity Scale (“Pain Right Now”) score = 5 accompanied by rescue medication of OXY IR at 1/4 the total daily oxycodone daily dose of OXY/OXN dosing = 2 times over one day. OR subjects may have a pain event by: 3) Study discontinuation due to lack of therapeutic effect. | — |
Countries
Czech Republic, Denmark, Hungary, Spain
Outcome results
None listed