Rheumatoid Arthritis Clinical Trial
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Elizabeth Hospital | Gascoigne Road | |
Hong Kong | Queen Mary Hospital (Dept of Anaesthesiology) | Pokfulam Road | |
Hong Kong | Queen Mary Hospital (Dept of Rheumatology) | Pokfulam Road | |
Hong Kong | Prince of Wales Hospital | Shatin | |
Hong Kong | Tuen Mun Hospital | Tuen Mun | |
Hong Kong | Pok Oi Hospital | Yuen Long | New Territories |
Korea, Republic of | Samsung Medical Center | Gangnam-Gu | Seoul |
Korea, Republic of | Seoul National University Hospital (Dept of Neurology) | Jongno-gu | Seoul |
Korea, Republic of | Seoul National University Hospital (Dept of Orthopedics) | Jongno-gu | Seoul |
Korea, Republic of | Seoul St. Mary's Hospital | Seocho-gu | Seoul |
Korea, Republic of | Severance Hospital | Seodaemun-gu | Seoul |
Korea, Republic of | Asan Medical Center | Songpa-Gu | Seoul |
Philippines | Makati Medical Center | Makati City | |
Philippines | Philippine General Hospital | Manila | |
Philippines | University of Santo Tomas Hospital | Manila | |
Philippines | St. Luke's Medical Center | Quezon City |
Lead Sponsor | Collaborator |
---|---|
Mundipharma Pte Ltd. | Mundipharma (Hong Kong) Ltd, Mundipharma Distribution GmBH (Philippine Branch), Mundipharma Korea Ltd |
Hong Kong, Korea, Republic of, Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy according to BS-11 pain score | The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. | Maximum 17 weeks starting from enrolment | No |
Secondary | Secondary efficacy outcome | Pre- and post-intervention EQ5D-3L quality of life score change and 8-items global sleep quality assessment (GSQA) score change. | approximately 17 weeks starting from enrolment | No |
Secondary | Adverse events | Side effects of the transdermal patch treatment will also be analysed. | From time of enrolment up to 7 days after completion / discontinuation visit | Yes |
Secondary | Secondary efficacy outcome | Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries. | Approximately 17 weeks starting from enrolment | No |
Secondary | Secondary efficacy outcome | Physicians' and patients' treatment satisfaction assessed using Physician's Global Impression of Change scale and Patient's Global Impression of Change scale respectively | At visit 6 | No |
Secondary | Secondary efficacy outcome | Incidence of early treatment discontinuation due to lack of efficacy. | Throughout study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |