The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
740
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
Placebo, divided into 2 doses, q12h
Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Randomized Baseline through Week 12
Time-to-exit From the Study for All Causes
Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.
Time frame: Randomization Baseline through Week 12
Percent Reduction in Pain Intensity for Responders
Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.
Time frame: Screening Baseline through Week 12
Weekly Changes in Pain Intensity
Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).
Time frame: Randomization Baseline and weekly through Week 12
Rescue Medication Usage by Dose
Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)
Time frame: Randomization Baseline through Week 12
Rescue Medication Use by Dosage
Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)
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Unnamed facility
Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Anaheim, California, United States
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Buena Park, California, United States
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Cerritos, California, United States
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Escondido, California, United States
Unnamed facility
La Mesa, California, United States
Unnamed facility
Napa, California, United States
...and 35 more locations
Time frame: Randomization Baseline through Week 12
Patient Global Impression of Change (PGIC)
The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse".
Time frame: Screening Baseline through Week 12
Changes in Quality of Life
Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.
Time frame: Randomization Baseline through Week 12
Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)
The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.
Time frame: Randomization Baseline and Week 12