Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Transdermal therapeutic system (TTS) fentanyl, Durogesic
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.
Detailed description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, unblinded), single-arm, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. The first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until Day 30 will be provided to the participant with the instructions to apply the patch. The TTS-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. Efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.
Interventions
DRUGTTS-fentanyl
Sponsors
Janssen-Cilag Ltd.,Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with stage II Kellgen-Lawrence, for more than 3 months with Visual Analogue Scale (VAS) more than 4 * Good knee deformity, no limit range of motion * Participant who has signed the informed consent form
Exclusion criteria
* Skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability * History or suspicion of alcohol or drug abuse within the past 5 years * History of cardiac, nervous system or respiratory disease which in the investigator's judgment prevents participation in the study because of the potential for respiratory depression * Confusion, reduced level of consciousness, or concomitant psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial * Participants who do not understand or speak Thai
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 | Baseline, Day 30 | The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst). |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TTS-Fentanyl Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TTS-Fentanyl |
|---|---|
| Age Continuous | 66.34 Years STANDARD_DEVIATION 6.11 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 1 Participants |
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Overall | 133.1 Millimeter (mm) STANDARD_DEVIATION 4.04 |
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Pain | 43.9 Millimeter (mm) STANDARD_DEVIATION 1.51 |
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Physical function | 47.6 Millimeter (mm) STANDARD_DEVIATION 1.12 |
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Stiffness | 41.6 Millimeter (mm) STANDARD_DEVIATION 1.92 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30
The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).
Time frame: Baseline, Day 30
Population: Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TTS-Fentanyl | Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 | Pain | -22.2 Millimeter (mm) |
| TTS-Fentanyl | Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 | Stiffness | -21.5 Millimeter (mm) |
| TTS-Fentanyl | Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 | Physical function | -29.5 Millimeter (mm) |
| TTS-Fentanyl | Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 | Overall | -73.2 Millimeter (mm) |