An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee. - Norspan efficacy and safety among elderly subjects

• Register: EUCTR
• Last refreshed on: 6 May 2013
• Main ID: EUCTR2010-020748-37-SE
• Date of registration: 07/10/2010
• Prospective Registration: Yes
• Primary sponsor: Mundipharma AB
• Public title: An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee. - Norspan efficacy and safety among elderly subjects
• Scientific title: An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee. - Norspan efficacy and safety among elderly subjects
• Date of first enrolment: 01/12/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020748-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Age-group controlled If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Age-group controlled

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Males and females aged 50-60 or = 75 years.
2. Subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of ACR-criteria and radiographic evidence not older than one year.
3. Subjects with a moderate to severe pain, confirmed by a BS-11 score = 4 for their pain on average during the Screening Phase in their primary OA-site at the Baseline Visit.
4. Subjects must be willing to stop their current OA pain treatment and replace it with sponsor provided paracetamol with maximum tolerated daily dose intake during the Screening Phase (= 2000mg but = 4000mg daily).
5. Female subjects of childbearing potential (including female subjects less than one year post-menopausal) must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective method of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as combined oral contraceptives, sterilization, implants, injectables, some IUDs (Intrauterine Device), or vasectomised partner.
6. Subjects must read and comprehend national language (Swedish) and be willing to sign informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects recording < 4 on average during the Screening Phase on the BS-11 scale.
2. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain.
3. Subjects treated with a regular dose for > 1 week of tramadol, codeine or dextropropoxiphene within 1 month before screening visit.
4. Subjects who require NSAID treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period.
5. Subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
6. Subjects scheduled for surgery that would fall within the study period.
7. Subjects who currently abused substance or alcohol, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
8. Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
9. Untreated depression or other psychiatric disorder in such way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
10. Subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the Investigator’s opinion, may pose a risk of additional CNS depression with study medication.
11. Subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants.
12. Dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
13. Subjects who hade received an intra-articular steroid injection within 6 weeks prior Screening Visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period.
14. Subjects with joint evacuation 6 weeks prior Screening Visit and during the study.
15. Subjects who are currently taking monoamine oxidase inhibitors (MAOI’s) or have taken MAOI’s within 2 weeks before Screening Visit.
16. Participation in a clinical research study involving a new chemical entity within 30 days before Screening Visit.
17. Subjects with known tolerance and/or lack of effect of buprenorphine.
18. Subjects with known allergy, hypersensitivity or other contraindications to opioids, transdermal delivery systems or patch adhesives.
19. Ongoing requirement for and treatment with direct external heat sources such as heat lamps, electric blankets, saunas, heating pads and heated waterbeds.
20. Subjects with new physiotherapy regimen scheduled to commence during Screening Phase or Treatment Phase of the study.
21. Subjects who cannot or will not cut the hair at the patch site for proper placement of the patch.
22. Any other contraindications listed in the Summary of Product Characteristics for Norspan.
23. Subjects who are unsuitable for any other reason to receive study medication in the opinion of the Investigator.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Osteoarthritis pain
MedDRA version: 12.1 Level: LLT Classification code 10031161 Term: Osteoarthritis

Intervention(s)

Trade Name: Norspan 5 mg
Product Name: Norspan 5 mg
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-25

Trade Name: Norspan 10 mg
Product Name: Norspan 10 mg
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-30

Trade Name: Norspan 20 mg
Product Name: Norspan 20 mg
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-40

Primary Outcome(s)

Main Objective: Evaluate the efficacy of buprenorphine transdermal patches in two different age groups: 50-60 years and >75 years

Primary end point(s): Box Scale-11 (BS-11) pain scores (pain on average during the last week), mean change from Baseline to Completion (fulfilled all visits in the study).

Secondary Objective: None

Secondary ID(s)

BUP4504