Osteoarthritis
Conditions
Keywords
OA, Elderly, Pain, OA of the hips and/or knees
Brief summary
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
Interventions
DRUGBuprenorphine
buprenorphine transdermal system 5, 10 and 20 mg
DRUGCodeine paracetamol
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Sponsors
Napp Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Either sex aged 65 or above * Diagnosis of OA of the hip and/or knee * Severe pain requiring step two medication * Taking maximum dose of paracetamol
Exclusion criteria
* Painful disease of the joints other than OA * Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS) * Subjects taking cyclooxygenase (COX) II selective inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pain Scores - BS11 Pain Scores. | every day over a 12 week study duration. | The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. |
Countries
United Kingdom
Participant flow
Recruitment details
Primary care. March 2006 to Aug 2007
Pre-assignment details
Screening for patient eligibility
Participants by arm
| Arm | Count |
|---|---|
| Buprenorphine Transdermal System Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days | 110 |
| Co-codamol Tablets combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 | 109 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 38 | 23 |
| Overall Study | Lack of Efficacy | 5 | 13 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 6 | 13 |
Baseline characteristics
| Characteristic | Buprenorphine Transdermal System | Co-codamol Tablets | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 90 Participants | 86 Participants | 176 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 23 Participants | 43 Participants |
| Sex: Female, Male Female | 75 Participants | 74 Participants | 149 Participants |
| Sex: Female, Male Male | 35 Participants | 35 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Average Daily Pain Scores - BS11 Pain Scores.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
Time frame: every day over a 12 week study duration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine Transdermal System | Average Daily Pain Scores - BS11 Pain Scores. | 3 Box Scale 11 boxes | Standard Deviation 1.31 |
| Co-codamol Tablets | Average Daily Pain Scores - BS11 Pain Scores. | 3 Box Scale 11 boxes | Standard Deviation 1.1 |