Chronic non-cancer pain Signs and Symptoms Other chronic pain
Conditions
Interventions
The duration of the study is six weeks. In the first phase all subjects will receive CR hydromorphone. In the second phase, subjects will be randomized to receive either CR hydromorphone or PRC-062 an
Sponsors
Purdue Pharma (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-nursing female subjects of 18 years of age or older 2. History of chronic non-cancer pain for six months or more 3. Subjects who at time of screening require stable doses of CR hydromorphone not exceeding 60 mg per day for a period of three months or more prior to entry into the study and who report satisfaction with their pain management
Exclusion criteria
Exclusion criteria: 1. Subjects who do not respond adequately to on-label dosing of CR hydromorphone at doses not exceeding 60 mg per day 2. Subjects with cancer 3. Inhaled cannabis use 4. Compromised kidney or liver function 5. Conditions that may adversely affect safety or obscure the assessment of efficacy 6. Risk for central nervous system (CNS) or respiratory depression 7. Significant gastrointestinal (GI) structural abnormalities or diseases/conditions that may affect bowel function 8. Major psychiatric disorder 9. Received an investigational drug in the past month 10. Taking monoamine oxidase (MAO) inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects in each arm who require a dose change from their pre-randomization CR hydromorphone dose, irrespective of when during the post-randomization period this dose change occurs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Magnitude of the mean dose change between treatment arms 2. Within-subject magnitude of the dose change from pre- to post-randomization 3. Rescue medication usage 4. Pain Intensity Questionnaire (PIQ), at weekly visits during the study 5. Beck Depression Inventory (BDI), at weekly visits during the study 6. Pain and Sleep Questionnaire 3 Item Index (PSQ-3), at weekly visits during the study 7. Pain and Disability Index (PDI), at weekly visits during the study 8. Treatment effectiveness and satisfaction, at weekly visits during the study 9. Global Impression of Change (GIC) scale, at weekly visits during the study 10. Subjective Opiate Withdrawal Scale (SOWS), at weekly visits during the study 11. Quality of life (SF-12) questionnaire, at weekly visits during the study 12. Brief Pain Inventory (BPI), at weekly visits during the study 13. Bowel Function Index (BFI), at weekly visits during the study 14. Laxative use The secondary endpoints of magnitude of the mean dose change between treatment arms, the within-subject magnitude of the dose change from pre- to post-randomization, laxative use and rescue medication use will be captured irrespective of when during the post-randomization period these changes occur. The mean change from baseline in all endpoints will be measured. | — |
Countries
Canada
Outcome results
None listed