Chronic non-cancer pain and bowel function Signs and Symptoms Pain, not elsewhere classified
Conditions
Interventions
Oral opioid analgesic (038) titrated to effect over a five-week phase with matched CR oxycodone arm.
Sponsors
Purdue Pharma Canada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-nursing female patients over the age of 18 years with chronic non-cancer pain of moderate or greater intensity for at least three months 2. Patients who require stable doses of 60 to 80 mg every 12 hours of oxycodone or its analgesic equivalent 3. Patients experiencing less than three complete, spontaneous bowel movements in the seven days prior to randomisation
Exclusion criteria
Exclusion criteria: 1. Patients who undergoing any treatments that may change their pain during the study, such as physiotherapy, corticosteroid injections or surgical procedures 2. Patients who do not respond adequately to doses of 60 or 80 mg every 12 hours of oxycodone 3. Patients whose pain is expected to be refractory to continuous opioid therapy 4. Patients with allergy to study drug 038, oxycodone or any other opioid 5. Patients with any of the following: 5.1. A condition that affects patient safety or obscures the assessment of efficacy 5.2. Compromised kidney or liver function 5.3. Risk for central nervous system (CNS) and/or respiratory depression 5.4. Significant gastrointestinal structural abnormalities or diseases/conditions that affect bowel function 5.5. A major psychiatric disorder 5.6. Received an investigational drug in the last month 5.7. Failed the urine drug screen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity and bowel function measured during the last week of treatment in each phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| All assessments measured during the last week of treatment in each phase: 1. ROME-III 2. Patient Assessment of Constipation Symptoms (PAC-SYM) 3. Brief Pain Inventory 4. Multidimensional Pain Inventory 5. Beck Depression Inventory 6. Pain Disability Index 7. Pain and Sleep Questionnaire 8. Level of Activity | — |
Countries
Canada
Outcome results
None listed