Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rh… (NCT01961271) | Clinical Trial Compass
CompletedPhase 4
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
Hong Kong114 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, who are not adequately responding to non-opioid painkillers.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Males and females aged 18-80 years (both inclusive) at the time of recruitment.
âś“. Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint / muscle pain.
✓. Having non-malignant pain of moderate or severe intensity requiring an opioid for adequate analgesia (according to local label of Norspan® or Sovenor®). This is to be determined using BS-11 scores, where the cut-off point is ≥4.
âś“. Patients with chronic uncontrolled pain and is assessed to require opioid treatment but have not been treated with opioids (including tramadol, morphine etc.) within 4 weeks or more before study entry.
Exclusion criteria
âś•. Pregnant and lactating females.
âś•. Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
âś•. Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative.
âś•. Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain.
âś•. Prior history of buprenorphine transdermal system use.
âś•. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids.
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What they're measuring
1
Efficacy According to BS-11 Pain Score Reduction
Timeframe: Maximum 17 weeks starting from enrolment