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Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain

CompletedPhase 4NCT01961271
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For Analgesia
Sponsor
Mundipharma Pte Ltd.
Collaborators
Mundipharma Korea Ltd; Mundipharma (Hong Kong) Ltd; Mundipharma Distribution GmBH (Philippine Branch)
Start date
2013-06
Primary completion
2015-01
Sex
All
Age range
from 18 Years to 80 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Hong Kong, Philippines, South Korea
Total sites listed
16

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Males and females aged 18-80 years (both inclusive) at the time of recruitment. 2. Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint / muscle pain. 3. 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. 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: 1. Pregnant and lactating females. 2. Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout). 3. Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative. 4. Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain. 5. Prior history of buprenorphine transdermal system use. 6. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids. 7. Patients with allergies or other contraindications to transdermal systems or patch adhesives. 8. Patients with dermatological disorders who may have problems applying patch or rotating patch placement area. 9. Patients with cancer (except for basal cell carcinoma) or history of cancer who have been diagnosed within five years prior to the first study visit (except for treated basal cell carcinoma). 10. Patients with conditions such as brain tumour, brain injury or raised intracranial pressure. 11. Patients with history of psychiatric disorder, uncontrollable epilepsy, untreated depression or other psychiatric disorders of a type that would make participation in the study an unacceptable risk to the patient. 12. Patients with any conditions causing poor cognitive function as assessed by the participating physician. 13. Patients with history of alcohol and drug abuse or patients who have demonstrated behaviour that suggests a dependency or drug abuse. 14. Patients currently taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system depression with study medication. 15. Patients who are currently being administered monoamin…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01961271