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Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02519387
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Mundipharma Pharmaceuticals Sdn. Bhd.

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE August 10, 2015
Results First Submitted Date  ICMJE May 15, 2016
Results First Posted Date  ICMJE July 20, 2016
Last Update Posted Date July 20, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
Efficacy of Buprenorphine Patch [ Time Frame: 3 months ]
The BS-11 pain score was the main efficacy outcome measured in this study and there were six visits during the three-month study period. BS-11 pain score was measured at the baseline visit (visit 0) and during each subsequent visit by the site investigator team. In between study visits, the BS-11 was recorded by the patient in the patient diary.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • 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:
    1. Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always
    2. Need for pain medication to sleep -- as above
    3. Need for sleep medication to sleep -- as above
    4. Awakened by pain at night -- as above
    5. Awakened by pain in the morning -- as above
    6. Pain affecting partner's sleep -- as above
    7. Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor
    8. 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
  • Sleep quality [ Time Frame: 3 months ]
    Using 8-item global sleep quality assessment
  • Quality of Life [ Time Frame: 3 months ]
    Using EQ-5D-3L quality-of-life assessment
  • Daily use of breakthrough pain medication [ 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 [ Time Frame: 3 months ]
    Using global impression of change assessment
  • Tolerability of buprenorphine patch determined by incidence of AEs [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity
Official Title  ICMJE 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
Brief Summary This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics. The primary objective was to assess the efficacy of buprenorphine transdermal patch for pain control among these patients.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Lower Back Pain
  • Joint Pain
  • Muscle Pain
Intervention  ICMJE Drug: Buprenorphine Transdermal Patch
Other Name: Sovenor®
Study Arms  ICMJE Experimental: Buprenorphine Transdermal Patch
Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Intervention: Drug: Buprenorphine Transdermal Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2015)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females aged 40 years and above 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 intensity requiring an opioid for adequate analgesia. This was determined using BS-11 scores, where the cut-off point is ≥4.
  4. Patients had to be opioid treatment naïve as defined by no opioid treatment (including tramadol, morphine etc.) in the preceding 1 month.
  5. Patients who have uncontrolled pain and had not responded to non-opioid analgesics for 1 month or more.
  6. Patients who provided informed consent.

Exclusion Criteria:

  1. Pregnant and lactating females.
  2. Patients with chronic condition(s), in addition to (osteoarthritis) OA, that required frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
  3. Patients who were awaiting a scheduled operation or other surgical procedure during study period.
  4. Prior history of being on opioids in the preceding one month prior to the study for the management of chronic non-malignant pain.
  5. Patients with history of allergic reactions against paracetamol/acetaminophen, Non Steroidal Anti-Inflammatory drugs (NSAIDs) and/or opioids.
  6. Patients with allergies or other contraindications to transdermal systems or patch adhesives.
  7. Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.
  8. Patients with cancer (except for basal cell carcinoma) or history of cancer who have been diagnosed within five years prior to the visit (except for treated basal cell carcinoma).
  9. Patients with conditions such as brain tumour, brain injury or raised intracranial pressure.
  10. 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.
  11. Patients with any conditions causing poor cognitive function as assessed by the participating physician.
  12. Patients with history of alcohol and drug abuse or patients who had demonstrated behaviour that suggests a dependency or drug abuse.
  13. Patients who were at the time taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system (CNS) depression with study medication.
  14. Patients who were at the time being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
  15. Patients who were at the time taking adjuvant analgesics such as anti-depressants (e.g. amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors (SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin).
  16. Patients who had received steroid treatment (intra-articular, intramuscular, oral, intravenous, epidural or other corticosteroid injections) within 6 weeks prior to clinical study or planned steroid treatment during the clinical study period.
  17. Patients who had to use heating facility over area of patch (examples: heating lamp, electric blanket, sauna, warm compresses, heated saline baths, etc.).
  18. Patients who could not or did not wish to remove hair growing at body surface where the patch can be placed.
  19. Any other contraindication mentioned in the Summary of Product Characteristics for Sovenor® transdermal patch.
  20. Patients who were at the time on disability claims or in the process of applying for disability claims.
  21. Patients at child-bearing age who were planning to conceive a child during the study period and were not practicing adequate contraception.
  22. Patients with known severe hepatic impairment as determined by liver function test within the past one year. If liver function testing was not performed within 1 year prior to study initiation, patient had to undergo liver function testing prior to recruitment.
  23. Patients who were at the time in or had participated in other clinical trials within the last 30 days prior to study recruitment.
  24. Patients who were unable to comply to study visits.
  25. Patients who, in the investigator's opinion, were not suited to participate in the study involving the study medicine for any other reason not stated in the inclusion/exclusion criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02519387
Other Study ID Numbers  ICMJE BUP11-MY-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma Pharmaceuticals Sdn. Bhd.
Study Sponsor  ICMJE Mundipharma Pharmaceuticals Sdn. Bhd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mundipharma Pharmaceuticals Sdn. Bhd.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP