The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).
This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram per hour (mcg/hr) or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
218
One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.
Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.
Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
Time frame: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Pain Visual Analog Scale (VAS) Score - Titration Period
The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.
Time frame: Day 12-14 (Screening period) and Day 27-29 (Titration period)
Pain Visual Analog Scale (VAS) Score - Double-Blind Period
The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.
Time frame: Day 27-29 (Titration period) and Day 83-85 (double-blind period)
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".
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Unnamed facility
Aki, Japan
Unnamed facility
Akō, Japan
Unnamed facility
Amagasaki, Japan
Unnamed facility
Anan, Japan
Unnamed facility
Annaka, Japan
Unnamed facility
Chiba, Japan
Unnamed facility
Chiisagata, Japan
Unnamed facility
Fuchū, Japan
Unnamed facility
Fukuoka, Japan
Unnamed facility
Fukuyama, Japan
...and 49 more locations
Time frame: Day 1 and 29 or final evaluation (Titration period)
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".
Time frame: Day 1 and 85 or final evaluation (double-blind period)
Number of Doses of Rescue Treatment Per Day - Titration Period
If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Time frame: Day 1 and 29 or final evaluation (Titration period)
Number of Doses of Rescue Treatment Per Day - Double-Blind Period
If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Time frame: Day 1 and 85 or final evaluation (double-blind period)
Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain.
Time frame: Day 1 and 29 or final evaluation (Titration period)
Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain.
Time frame: Day 1 and 85 or final evaluation (double-blind period)
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Time frame: Day 1 and 29 or final evaluation (Titration period)
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Time frame: Day 1 and 85 or final evaluation (double-blind period)
Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Time frame: Day 29 or final evaluation (Titration period)
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Time frame: Day 1 and 85 or final evaluation (double-blind period)