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A prospective, multicenter, observational study for buprenorphine transdermal patch (Norspan) in the treatment of osteoarthrosis patients with chronic pain

A prospective, multicenter, observational study for buprenorphine transdermal patch (Norspan) in the treatment of osteoarthrosis patients with chronic pain

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013583
Enrollment
Unknown
Registered
2017-11-28
Start date
2017-12-15
Completion date
Unknown
Last updated
2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthrosis patients with chronic pain

Interventions

study group:buprenorphine transdermal patch 5mg/7days for 4 weeks

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female aged 18 years or older; 2. Patient has been diagnosed as including but not limited to OA, or sacroiliitis, or retrograde spondylitis, or myofascitis; 3. Patient suffered from pain persisting for four weeks or longer; 4. Patient experienced invalid pain relief while taking non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol, or has NSAIDs contraindications; 5. Patient has an 'average pain over the last week' score at primary pain site of greater than or equal to 4 evaluated by one question (Please rate your pain by circling the one number that best describes your pain on the average pain over the last week) from Brief Pain Inventory (BPI); 6. Patient provides informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient with a history of the drug or alcohol abuse. 2. Prior history of buprenorphine transdermal patch use. 3. Patient with allergies or other contraindications to transdermal systems or patch adhesives. 4. Patient with cancer pain. 5. patient with pain caused by Infectious disease; 6. Patient who participated in a clinical research study within one month of study entry; 7. Pregnant and lactating woman; 8. Patient who is not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug (at the investigators discretion).

Design outcomes

Primary

MeasureTime frame
Change of an average pain intensity over 24 hours from baseline through final evaluation as measured by BPI;

Secondary

MeasureTime frame
To evaluate other patients’ pain relief parts using BPI scale from baseline through final evaluation;Quality of Life;Physician's and patient's satisfaction of using buprenorphine transdermal patch;early discontinuation;To describe the daily use of breakthrough pain medication by patients using buprenorphine transdermal patch;To describe the optimal dose level of buprenorphine transdermal patch at the end of titration;To describe the incidence and severity of adverse events of buprenorphine transdermal patch;

Countries

China

Contacts

Public ContactPei Fuxing

West China Hospital, Sichuan University

peifuxing@vip.163.com+86 18980601380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026