Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
|ClinicalTrials.gov Identifier: NCT01685684|
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Oxycodone DETERx Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||740 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain|
|Study Start Date :||August 2012|
|Primary Completion Date :||June 2014|
|Study Completion Date :||July 2014|
|Experimental: Oxycodone DETERx||
Drug: Oxycodone DETERx
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
|Placebo Comparator: Placebo||
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 [ Time Frame: Randomized Baseline through Week 12 ]The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
- Time-to-exit From the Study for All Causes [ Time Frame: Randomization Baseline through Week 12 ]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.
- Percent Reduction in Pain Intensity for Responders [ Time Frame: Screening Baseline through Week 12 ]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.
- Weekly Changes in Pain Intensity [ Time Frame: Randomization Baseline and weekly through Week 12 ]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).
- Rescue Medication Usage by Dose [ Time Frame: Randomization Baseline through Week 12 ]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)
- Rescue Medication Use by Dosage [ Time Frame: Randomization Baseline through Week 12 ]Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)
- Patient Global Impression of Change (PGIC) [ Time Frame: Screening Baseline through Week 12 ]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".
- Changes in Quality of Life [ Time Frame: Randomization Baseline through Week 12 ]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.
- Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Randomization Baseline and Week 12 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685684
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|Study Director:||Diana Meske, PhD||Collegium Pharmaceutical, Inc.|