Low Back Pain
Conditions
Keywords
Low back pain, Chronic pain, Opioid, Constipation, Moderate to severe chronic low back pain
Brief summary
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
Interventions
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
DRUGPlacebo
Placebo tablets to match OXN or OXY taken orally every 12 hours
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; * The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; * Subjects must have a self-reported history of opioid induced constipation (OIC).
Exclusion criteria
include: * Subjects with rheumatoid arthritis or other inflammatory arthritis; * Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; * Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility; * Subjects with chronic constipation not related to opioid use; * Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; * Subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated. Other protocol specific inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall complete spontaneous bowel movement (CSBM) responder rates | Weeks 1 through 12 | The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY |
Secondary
| Measure | Time frame |
|---|---|
| CSBM Responder at least 50% of the weeks in the double-blind period | Weeks 1 through 12 |
| Laxative-free Responder at least 50% of the weeks in the double-blind period | Weeks 1 through 12 |
Countries
Czechia, Italy, Poland, United States
Outcome results
None listed