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 Kong, Philippines, South Korea114 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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females aged 18-80 years (both inclusive) at the time of recruitment.
. 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.
. 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
. Pregnant and lactating females.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy According to BS-11 Pain Score Reduction
Timeframe: Maximum 17 weeks starting from enrolment
. Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
. Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative.
. Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain.
. Prior history of buprenorphine transdermal system use.
. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids.
. Patients with allergies or other contraindications to transdermal systems or patch adhesives.
. Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.