Prospective

Winnie Samy

Dept of Anaesthesia & Intensive Care, CUHK

2632 3155

wsamy@cuhk.edu.hk

Dept of Anaesthesia & Intensive Care, CUHK

Simon KC Chan

Dept of Anaesthesia & Intensive Care, CUHK

2632 2734

simonkcchan@cuhk.edu.hk

Dept of Anaesthesia & Intensive Care, CUHK

對因患有骨關節炎、類風濕性關節炎、腰背痛及關節／肌肉疼痛而引起中度至嚴重非癌病痛症並需要鴉片類藥物作適量止痛的患者，進行有關評估丁丙諾啡(Buprenorphine) 皮膚藥貼（Norspan®皮膚藥貼）的效用及安全性的多中心研究

Yes

2013-06-04

Drug

This is a phase IV post-registration study of buprenorphine transdermal patch (Norspan®) which will be conducted in various countries in Asia. The primary objective of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan®) in patients with chronic non-cancer 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 analgesics. The sleep quality, quality of life and safety are also assessed.
Patient upon recruitment into the study will be started on Norspan® 5mg patch (1 patch per week), and the dose can be titrated up to maximum 40mg patch in the titration period (maximun 42 days). Patient will then be using the optimum dosage for 11 weeks, and follow-up for another 2 weeks after treatment period.

maximum 19 weeks

N/A

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.
5.Patients who have provided informed consent.

1.Pregnant and lactating females.
2.Patients with chronic condition(s), in addition to OA, 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 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 CNS 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. anti-depressants (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.Any other contraindication mentioned in the Summary of Product Characteristics for Norspan® or Sovenor® transdermal patch.
21.Patients who are currently on disability claims or in the process of applying for disability claims.
22.Patients at child-bearing age who are planning to conceive a child during the study period and are not practicing adequate contraception.
23.Patients with known severe hepatic impairment as determined by liver function test within the past one year.
24.Patients who are currently in or have participated in other clinical trials within the last 30 days prior to study recruitment.
25.Patients who are unable to comply to study visits.
26.Patients who, in the investigator’s opinion, are not suited to participate in the study involving the study medicine for any other reason not stated in the inclusion/exclusion criteria.

18

80

Both Male and Female

Non-randomized

Active

Open label

Single group

No

No

nil