Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity
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|ClinicalTrials.gov Identifier: NCT02519387|
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 20, 2016
Last Update Posted : July 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Rheumatoid Arthritis Lower Back Pain Joint Pain Muscle Pain||Drug: Buprenorphine Transdermal Patch||Phase 4|
Buprenorphine transdermal (BTDs) is a semi-synthetic opioid analgesic. Earlier studies have shown BTDs to be non-inferior to an oral codeine-paracetamol combination and prolonged-release tramadol, in terms of pain control as well as sleep quality. BTDs is registered for use in Malaysia but the scientific data on efficacy and tolerability among Malaysians was not available. Thus, this study was conducted to evaluate the efficacy and tolerability of BTDs among Malaysian patients.
Patients eligible for entry into the study were adults aged ≥ 40 years who met the inclusion criteria and qualified from baseline screening and liver function test (LFT) assessment. The study excluded patients who met the exclusion criteria and failed prior the LFT assessment. Patients received an initial dose of 5 mg BTDs after qualifying on the baseline screening and LFT test. The dose could be up-titrated to a maximum of BTDs 20mg (2 X 10 mg) to achieve stable pain control.
There were six visits during the three-month study period. At visit 1, patients received 5mg of Sovenor® as initial treatment dose. Visit 2 occurred 7 days after the first visit; visit 2 and visit 3 were dose titration visits. Visit 4 and visit 5, were for assessment purposes. Primary treatment efficacy was measured during each visit with additional assessments of patients' sleep quality and quality of life, while physicians' and patients' treatment satisfaction assessed during the final visit. Safety was measured by monitoring the occurrence of adverse events (AEs).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Buprenorphine Transdermal Patch
Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Drug: Buprenorphine Transdermal Patch
Other Name: Sovenor®
- Change in Box Scale-11 (BS-11) Pain Score [ Time Frame: Baseline,3 months ]
The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.
BS-11 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.
- Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) [ Time Frame: Baseline, 3 months ]
Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).
The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:
- Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always
- Need for pain medication to sleep -- as above
- Need for sleep medication to sleep -- as above
- Awakened by pain at night -- as above
- Awakened by pain in the morning -- as above
- Pain affecting partner's sleep -- as above
- Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor
- Number of hours of sleep per night in last 7 days
- Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage [ Time Frame: 3 months ]Patients will record any other pain medication used in a patient home diary
- Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively [ Time Frame: 3 months ]
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"
- Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519387
|Hospital University Sains Malaysia|
|Kota Bahru, Kelantan, Malaysia, 10200|
|University Malaya Medical Centre|
|Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603|
|University Kebangsaan Malaysia Medical Centre|
|Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000|