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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Mundipharma Pte Ltd.
Sponsor:
Collaborators:
Mundipharma Korea Ltd
Mundipharma (Hong Kong) Ltd
Mundipharma Distribution GmBH (Philippine Branch)
Mundipharma (China) Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01961271
First received: October 7, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Lower Back Pain
Joint Pain
Muscle Pain
Drug: Buprenorphine transdermal patch
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Efficacy according to BS-11 pain score [ Time Frame: Maximum 17 weeks starting from enrolment ] [ Designated as safety issue: No ]
    The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score.


Secondary Outcome Measures:
  • Secondary efficacy outcome [ Time Frame: approximately 17 weeks starting from enrolment ] [ Designated as safety issue: No ]
    Pre- and post-intervention EQ5D-3L quality of life score change and 8-items global sleep quality assessment (GSQA) score change.

  • Adverse events [ Time Frame: From time of enrolment up to 7 days after completion / discontinuation visit ] [ Designated as safety issue: Yes ]
    Side effects of the transdermal patch treatment will also be analysed.

  • Secondary efficacy outcome [ Time Frame: Approximately 17 weeks starting from enrolment ] [ Designated as safety issue: No ]
    Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.

  • Secondary efficacy outcome [ Time Frame: At visit 6 ] [ Designated as safety issue: No ]
    Physicians' and patients' treatment satisfaction assessed using Physician's Global Impression of Change scale and Patient's Global Impression of Change scale respectively

  • Secondary efficacy outcome [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
    Incidence of early treatment discontinuation due to lack of efficacy.


Estimated Enrollment: 230
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine transdermal patch
Subjects 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.
Drug: Buprenorphine transdermal patch
Please see Arm Description.
Other Names:
  • Norspan transdermal patch
  • Sovenor transdermal patch

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged 18-80 years (both inclusive) 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 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.
  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.

Exclusion Criteria:

  1. Pregnant and lactating females.
  2. Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
  3. Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative.
  4. Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain.
  5. Prior history of buprenorphine transdermal system use.
  6. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids.
  7. Patients with allergies or other contraindications to transdermal systems or patch adhesives.
  8. Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.
  9. 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).
  10. Patients with conditions such as brain tumour, brain injury or raised intracranial pressure.
  11. 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.
  12. Patients with any conditions causing poor cognitive function as assessed by the participating physician.
  13. Patients with history of alcohol and drug abuse or patients who have demonstrated behaviour that suggests a dependency or drug abuse.
  14. Patients currently taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system depression with study medication.
  15. Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
  16. Patients requiring dose titration of adjuvant analgesics i.e. antidepressants (e.g. amitriptyline, amoxapine, clomipremine, 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.
  17. 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.
  18. Patients who have to use heating facility (examples: heating lamp, electric blanket, sauna, warm compresses, heated saline baths, etc.).
  19. Patients who cannot or do not wish to remove hair growing at body surface where the patch can be placed.
  20. Patients who are currently on disability claims or in the process of applying for disability claims.
  21. Patients at child-bearing age who are planning to conceive a child during the study period and are not practicing adequate contraception.
  22. Patients with known severe hepatic impairment as determined by liver function test within the past one year.
  23. Patients who are currently in or have participated in other clinical trials within the last 30 days prior to study recruitment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961271

Contacts
Contact: Abhishek Bhagat +65 6511 1167 info.rma@mundipharma.com.sg
Contact: Valerie A Leck +65 6511 3681 info.rma@mundipharma.com.sg

Locations
Korea, Republic of
Samsung Medical Center Completed
Gangnam-Gu, Seoul, Korea, Republic of, 135710
Seoul National University Hospital (Dept of Neurology) Recruiting
Jongno-gu, Seoul, Korea, Republic of, 110744
Seoul National University Hospital (Dept of Orthopedics) Recruiting
Jongno-gu, Seoul, Korea, Republic of, 110744
Seoul St. Mary's Hospital Completed
Seocho-gu, Seoul, Korea, Republic of, 137701
Severance Hospital Completed
Seodaemun-gu, Seoul, Korea, Republic of, 120752
Asan Medical Center Recruiting
Songpa-Gu, Seoul, Korea, Republic of, 138736
Sponsors and Collaborators
Mundipharma Pte Ltd.
Mundipharma Korea Ltd
Mundipharma (Hong Kong) Ltd
Mundipharma Distribution GmBH (Philippine Branch)
Mundipharma (China) Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01961271     History of Changes
Other Study ID Numbers: BUP12-AP-401
Study First Received: October 7, 2013
Last Updated: October 30, 2013
Health Authority: Philippines : Food and Drug Administration
South Korea: Institutional Review Board
Hong Kong: Department of Health

Keywords provided by Mundipharma Pte Ltd.:
chronic pain
lower back pain
joint pain
muscle pain
Norspan
buprenorphine
transdermal
patch
non-malignant
osteoarthritis
rheumatoid arthritis
opioid
analgesic
painkiller
Mundipharma

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Musculoskeletal Pain
Pain
Arthralgia
Arthritis
Arthritis, Rheumatoid
Myalgia
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Rheumatic Diseases
Signs and Symptoms
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014