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.
Baseline assessment (Visit 1) includes medical history, physical examination, vital signs. At Visit 2 \[7 days ( ± 3 days) after Visit 1\] and subsequent optional titration visits up to (Visit 1 + 42 days) , patients will be titrated up to an effective and tolerated dose of Norspan® or Sovenor® transdermal patch and continue rescue analgesic, if necessary. Titration period is dependent on time to achieving optimal pain control as determined by the investigator. The up-titration regime is planned on a weekly basis. Earlier dose titration (i.e. minimum 3 days after the patch application) is permitted at the investigator's discretion if the pain is uncontrolled. Effective and tolerated dose is assessed by data recorded in the case report form and patient diary. According to country label, all patients will begin treatment with Norspan® or Sovenor® transdermal patch 5mg and will then be up-titrated, if necessary, to a maximum of Norspan® or Sovenor® transdermal patch 40mg or according to country label to achieve stable pain control. Patients that require oral opioid at any time during the study should be discontinued from the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Please see Arm Description.
Pok Oi Hospital
Yuen Long, New Territories, Hong Kong
Queen Elizabeth Hospital
Gascoigne Road, Hong Kong
Queen Mary Hospital (Dept of Anaesthesiology)
Pokfulam Road, Hong Kong
Queen Mary Hospital (Dept of Rheumatology)
Pokfulam Road, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Tuen Mun Hospital
Tuenmen, Hong Kong
Makati Medical Center
Makati City, Philippines
Philippine General Hospital
Manila, Philippines
University of Santo Tomas Hospital
Manila, Philippines
St. Luke's Medical Center
Quezon City, Philippines
...and 6 more locations
Efficacy According to BS-11 Pain Score Reduction
The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score. BS-11 is known as "Box scale-11"; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time.
Time frame: Maximum 17 weeks starting from enrolment
Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention
Pre-intervention: Visit 1 Post-intervention: Visit 6 There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here: Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed
Time frame: approximately 17 weeks starting from enrolment
Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE
Side effects of the transdermal patch treatment will be analysed.
Time frame: From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)
Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication
Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.
Time frame: Approximately 17 weeks starting from enrolment
Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively
The overall assessment of the change in pain intensity from baseline is measured at Visit 6. Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is "very much improved" and 7 is "very much worse" Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is "very much improved" and 7 is "very much worse"
Time frame: At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)
Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.
Time frame: From time of enrolment to Visit 6 (ie. up to119 days from enrolment)
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