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OsteoarthritisPhase 4NCT01961271

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

A Phase 4 study testing Buprenorphine transdermal patch in people with Osteoarthritis and Rheumatoid Arthritis, run by Mundipharma Pte Ltd. at 16 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Buprenorphine transdermal patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
16 sitesin 3 countries
Study dates
Jun 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 18-80 years (both inclusive) at the time of recruitment.
  • Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint / muscle pain.
  • 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.
  • 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.

Who cannot join

  • Pregnant and lactating females.
  • Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
  • Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative.
  • Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain.
  • Prior history of buprenorphine transdermal system use.
  • Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids.
Show all 23Show fewer
  • Patients with allergies or other contraindications to transdermal systems or patch adhesives.
  • 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 first study 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 have demonstrated behaviour that suggests a dependency or drug abuse.
  • Patients currently taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system depression with study medication.
  • Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
  • Patients requiring dose titration of adjuvant analgesics i.e. antidepressants (e.g. amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors (SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin). Patients will be allowed to enter the study as long as they are on the stable doses of adjuvant analgesics at screening and do not have dose adjustments during the study.
  • Patients who have 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 have to use heating facility (examples: heating lamp, electric blanket, sauna, warm compresses, heated saline baths, etc.).
  • Patients who cannot or do not wish to remove hair growing at body surface where the patch can be placed.
  • Patients who are currently on disability claims or in the process of applying for disability claims.
  • Patients at child-bearing age who are planning to conceive a child during the study period and are not practicing adequate contraception.
  • Patients with known severe hepatic impairment as determined by liver function test within the past one year.
  • Patients who are currently in or have participated in other clinical trials within the last 30 days prior to study recruitment.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

Hong Kong6 sites

  • Queen Elizabeth Hospital

    Gascoigne Road

  • Queen Mary Hospital (Dept of Anaesthesiology)

    Pokfulam Road

  • Queen Mary Hospital (Dept of Rheumatology)

    Pokfulam Road

  • Prince of Wales Hospital

    Shatin

  • Tuen Mun Hospital

    Tuenmen

  • Pok Oi Hospital

    Yuen Long, New Territories

Other trials in Hong Kong

South Korea6 sites

  • Samsung Medical Center

    Gangnam-Gu, Seoul, 135710

  • Seoul National University Hospital (Dept of Neurology)

    Jongno-gu, Seoul, 110744

  • Seoul National University Hospital (Dept of Orthopedics)

    Jongno-gu, Seoul, 110744

  • Seoul St. Mary's Hospital

    Seocho-gu, Seoul, 137701

  • Severance Hospital

    Seodaemun-gu, Seoul, 120752

  • Asan Medical Center

    Songpa-Gu, Seoul, 138736

Other trials in South Korea

Philippines4 sites

  • Makati Medical Center

    Makati City

  • Philippine General Hospital

    Manila

  • University of Santo Tomas Hospital

    Manila

  • St. Luke's Medical Center

    Quezon City

Other trials in Philippines

About this study

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

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.

Read the detailed description

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.

Being tested
Buprenorphine transdermal patch
Keywords
Norspan, buprenorphine, transdermal, patch, chronic pain, non-malignant, osteoarthritis, rheumatoid arthritis, lower back pain, joint pain, muscle pain, opioid, analgesic, painkiller, Mundipharma
Medical subject headings
Osteoarthritis, Arthritis, Rheumatoid, Low Back Pain, Arthralgia, Myalgia, Chronic Pain

What participants receive

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

  • Buprenorphine transdermal patchDrug

    Also called Norspan transdermal patch, Sovenor transdermal patch

    Please see Arm Description.

Study groups in NCT01961271
Study groupRoleWhat they receive
Buprenorphine transdermal patchExperimentalSubjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Receives: Drug: Buprenorphine transdermal patch

What is being measured

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

  1. 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.

    Measured: Maximum 17 weeks starting from enrolment

Secondary outcomes (5)

  1. 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

    Measured: approximately 17 weeks starting from enrolment

  2. 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.

    Measured: From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)

  3. 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.

    Measured: Approximately 17 weeks starting from enrolment

  4. 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"

    Measured: At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)

  5. Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.

    Measured: From time of enrolment to Visit 6 (ie. up to119 days from enrolment)

Timeline

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

  1. First posted11 Oct 2013 (estimated)
  2. Study startJun 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
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961271
Sponsor's protocol ID
BUP12-AP-401
Status last verified
Aug 2016
First submitted
7 Oct 2013
Last updated
23 Sep 2016
Data monitoring committee
No

Publications

  • Yoon DH, Bin SI, Chan SK, Chung CK, In Y, Kim H, Lichauco JJ, Mok CC, Moon YW, Ng TK, Penserga EG, Shin DA, You D, Moon H. Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain. BMC Musculoskelet Disord. 2017 Aug 4;18(1):337. doi: 10.1186/s12891-017-1664-4.

    PubMed 28778219

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 Pte Ltd. at 16 sites in 3 countries.

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 4 inclusion and 23 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Hong Kong, South Korea, Philippines. 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 23 Sep 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?

Efficacy According to BS-11 Pain Score Reduction (time frame: Maximum 17 weeks starting from enrolment). 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 NCT01961271, which also lists 1 linked publication.

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 23 Sep 2016.

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