Study of PRC-062 in patients with chronic non-cancer pai
- Conditions
- Chronic non-cancer painSigns and SymptomsOther chronic pain
- Registration Number
- ISRCTN54273961
- Lead Sponsor
- Purdue Pharma (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method