Pain; Cancer
Conditions
Keywords
Pain; Cancer, TTS-Fentanyl D-trans, Durogesic D-trans
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.
Detailed description
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.
Interventions
DRUGFentanyl D-trans
Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who complains of cancer pain * Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours * Participants with an estimated life expectancy of at least 2 months * Participants who are able to communicate with the investigator * Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period
Exclusion criteria
* Participants participating in another clinical trial * Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse * Participants who have active skin disease, avoiding application of the transdermal system * Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease) * Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Satisfied With Pain Treatment | Day 29 | Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | Day 1 and Day 29 | Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Day 29 | Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other. |
| Initial and End Point Dose of TTS-Fentanyl D-trans | Day 1 and Day 29 | Dose of TTS-fentanyl D-trans were monitored at start and end of the trial. |
| Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Day 29 | Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Other | 16 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Transdermal Therapeutic System (TTS)-Fentanyl D-trans |
|---|---|
| Age, Continuous | 60.81 years STANDARD_DEVIATION 12.93 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 103 |
| serious Total, serious adverse events | 18 / 103 |
Outcome results
Primary
Percentage of Participants Satisfied With Pain Treatment
Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.
Time frame: Day 29
Population: Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Percentage of Participants Satisfied With Pain Treatment | 82.81 percentage of participants |
Secondary
Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans
Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.
Time frame: Day 1 and Day 29
Population: Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | Day 1 | 6.61 units on a scale | Standard Deviation 1.62 |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | Day 29 | 3.66 units on a scale | Standard Deviation 2.42 |
Other Pre-specified
Initial and End Point Dose of TTS-Fentanyl D-trans
Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.
Time frame: Day 1 and Day 29
Population: Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Initial and End Point Dose of TTS-Fentanyl D-trans | Initial dose | 12.00 microgram per hour (mcg/hr) | Standard Deviation 0 |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Initial and End Point Dose of TTS-Fentanyl D-trans | End-point dose | 26.47 microgram per hour (mcg/hr) | Standard Deviation 19.05 |
Other Pre-specified
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment
Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.
Time frame: Day 29
Population: Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Excellent pain relieving effect | 32 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Convenient administration | 24 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Minor adverse event | 4 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Generally Satisfied | 15 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Other | 0 participants |
Other Pre-specified
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment
Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.
Time frame: Day 29
Population: Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Very Satisfied | 16 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Satisfied | 43 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Average | 9 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Dissatisfied | 0 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Very Dissatisfied | 1 participants |