Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pai
- Conditions
- Moderate to severe painNeurological - Other neurological disorders
- Registration Number
- ACTRN12605000696695
- Lead Sponsor
- Mundipharma Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
1. Treatment with opioid analgesic for at least past 4 weeks. 2. Prior opioid analgesic equivalent to 80mg morphine or greater. 3. Pain score less than, or equal to, 4 over 24 hour period for last two consecutive days. 4. Rescue doses less than, or equal to, three doses over 24 hour period for the last two consecutive days.
Exclusion Criteria
History of alcohol or drug abuse, unstable pain, high dose systemic corticosteroid therapy excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method