Osteoarthritis
Conditions
Keywords
Osteoarthritis, 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 patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
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 following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through 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
TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Sponsors
Janssen-Cilag Ltd.,Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with Visual Analog Scale (VAS) greater than or equal to 5 * Participants having moderate to severe pain (VAS greater than or equal to 5), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 150 milligram \[mg\] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days * Participants who failed from other treatments such as operation or lack of efficacy of current treatment
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 precludes participation in the study because of the potential for respiratory depression * Confusion, reduced level of consciousness, or concomitant (given at the same time) psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial * Pregnant or breast-feeding female; female participants of child bearing potential without adequate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score at Day 15 | Day 15 | The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain. |
| Pain Intensity Score at Day 30 | Day 30 | The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | Baseline, Day 15 and Day 30 | The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl 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 |
Baseline characteristics
| Characteristic | Transdermal Therapeutic System (TTS)-Fentanyl |
|---|---|
| Age Continuous | 66.03 Years STANDARD_DEVIATION 8.25 |
| Pain Intensity Score by Visual Analog Scale (VAS) | 7.86 Centimeter [cm] STANDARD_DEVIATION 2.02 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Pain Intensity Score at Day 15
The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.
Time frame: Day 15
Population: Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N signifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Pain Intensity Score at Day 15 | 6.61 cm | Standard Deviation 2.93 |
Primary
Pain Intensity Score at Day 30
The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.
Time frame: Day 30
Population: ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N signifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Pain Intensity Score at Day 30 | 6.00 cm | Standard Deviation 3.31 |
Secondary
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30
The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Time frame: Baseline, Day 15 and Day 30
Population: ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N signifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | Baseline | 17.04 Units on a scale | Standard Deviation 4.38 |
| Transdermal Therapeutic System (TTS)-Fentanyl | Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | Day 15 | 14.84 Units on a scale | Standard Deviation 5.4 |
| Transdermal Therapeutic System (TTS)-Fentanyl | Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | Day 30 | 13.41 Units on a scale | Standard Deviation 6.44 |