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OsteoarthritisPhase 4NCT02519387

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

A Phase 4 study testing Buprenorphine Transdermal Patch in people with Osteoarthritis and Rheumatoid Arthritis, run by Mundipharma Pharmaceuticals Sdn. Bhd. at 3 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Buprenorphine Transdermal Patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
3 sitesMalaysia
Study dates
Jul 2013to Jan 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 40 years and above at the time of recruitment.
  • Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint/muscle pain.
  • 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.
  • Patients had to be opioid treatment naïve as defined by no opioid treatment (including tramadol, morphine etc.) in the preceding 1 month.
  • Patients who have uncontrolled pain and had not responded to non-opioid analgesics for 1 month or more.
  • Patients who provided informed consent.

Who cannot join

  • Pregnant and lactating females.
  • Patients with chronic condition(s), in addition to (osteoarthritis) OA, that required frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
  • Patients who were awaiting a scheduled operation or other surgical procedure during study period.
  • Prior history of being on opioids in the preceding one month prior to the study for the management of chronic non-malignant pain.
  • Patients with history of allergic reactions against paracetamol/acetaminophen, Non Steroidal Anti-Inflammatory drugs (NSAIDs) and/or opioids.
  • Patients with allergies or other contraindications to transdermal systems or patch adhesives.
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  • Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.
  • 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).
  • Patients with conditions such as brain tumour, brain injury or raised intracranial pressure.
  • 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.
  • Patients with any conditions causing poor cognitive function as assessed by the participating physician.
  • Patients with history of alcohol and drug abuse or patients who had demonstrated behaviour that suggests a dependency or drug abuse.
  • 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.
  • Patients who were at the time being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
  • 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).
  • 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.
  • Patients who had to use heating facility over area of patch (examples: heating lamp, electric blanket, sauna, warm compresses, heated saline baths, etc.).
  • Patients who could not or did not wish to remove hair growing at body surface where the patch can be placed.
  • Any other contraindication mentioned in the Summary of Product Characteristics for Sovenor® transdermal patch.
  • Patients who were at the time on disability claims or in the process of applying for disability claims.
  • Patients at child-bearing age who were planning to conceive a child during the study period and were not practicing adequate contraception.
  • 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.
  • Patients who were at the time in or had participated in other clinical trials within the last 30 days prior to study recruitment.
  • Patients who were unable to comply to study visits.
  • 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.

Trial locations and contacts

3 sites in 1 country.

Malaysia3 sites

  • Hospital University Sains Malaysia

    Kota Bharu, Kelantan, 10200

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 50603

  • University Kebangsaan Malaysia Medical Centre

    Kuala Lumpur, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

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

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.

Read the 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).

Being tested
Buprenorphine Transdermal Patch
Medical subject headings
Osteoarthritis, Arthritis, Rheumatoid, Low Back Pain, Arthralgia, Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine Transdermal PatchDrug

    Also called Sovenor®

Study groups in NCT02519387
Study groupRoleWhat they receive
Buprenorphine Transdermal PatchExperimentalBuprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Receives: Drug: Buprenorphine Transdermal Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Box Scale-11 (BS-11) Pain Score

    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.

    Measured: Baseline,3 months

Secondary outcomes (4)

  1. Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)

    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

    Measured: Baseline, 3 months

  2. Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage

    Patients will record any other pain medication used in a patient home diary

    Measured: 3 months

  3. 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

    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"

    Measured: 3 months

  4. Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519387
Sponsor's protocol ID
BUP11-MY-401
Status last verified
Jul 2016
First submitted
15 Jul 2015
Last updated
20 Jul 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Buprenorphine Transdermal Patch in people with Osteoarthritis and Rheumatoid Arthritis, run by Mundipharma Pharmaceuticals Sdn. Bhd. at 3 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Box Scale-11 (BS-11) Pain Score (time frame: Baseline,3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02519387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.

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