Phase 3
Completed N=156
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
Source: ClinicalTrials.gov NCT00644787 ↗Enrolled (actual)
156
Serious AEs
12.4%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants Achieving Dose Titration Success — 80.60 Percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Dose Titration Success |
80.60 | — |
| PRIMARY Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase |
18.4; 20.6; -1.1; -2.5 | — |
| SECONDARY Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase |
1; 9; 54; 83; 8; 4 | — |
| SECONDARY Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase |
3; 4; 31; 37; 19; 16 | — |
| SECONDARY Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase |
56.8; 45.0; 41.9; 35.7; 32.7; 32.8 | — |
| SECONDARY Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase |
16.5; 18.6; 18.2; 18.4; 21.5; 17.8 | — |
| SECONDARY Percentage of Participants Achieving Pain Control in Double Blind Phase |
83.3; 90.0 | — |
| SECONDARY Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase |
0; 23; 115; 17; 4; 54 | — |
| SECONDARY Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase |
6; 10; 39; 37; 9; 12 | — |
| SECONDARY Number of Participants With Total Duration of Pain Per Day in Titration Phase |
36; 38; 22; 24; 35; 52 | — |
| SECONDARY Number of Participants With Total Duration of Pain Per Day in Double Blind Phase |
44; 46; 5; 5; 2; 7 | — |
| SECONDARY Mean Number of Rescue Doses in Titration Phase |
0.3; 0.8; 0.7; 0.6; 0.5; 0.7 | — |
| SECONDARY Mean Number of Rescue Doses in Double Blind Phase |
0.1; 0.2; 0.3; 0.4; 0.3; 0.4 | — |
| SECONDARY Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase |
145; 9 | — |
| SECONDARY Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase |
53; 58; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with cancer pain who were previously not treated with opioid analgesics (drug used to control pain)
- Participants with a pain score of greater than or equal to 35 millimeter (mm) on a 100-mm visual analog scale (VAS)
- Participants who are considered to have "insufficient response" to non-opioid analgesics and require treatment with opioid analgesics by the physician
- Participants who have an established diagnosis of cancer and are notified of the disease
- Participants who can be hospitalized during Period 1 (dose-titration period)
Exclusion Criteria
- Participants with impaired respiratory function due to chronic lung disease or others
- Participants with asthma (breathing disorder in which there is wheezing and difficulty in breathing)
- Participants with bradyarrhythmia (slow, irregular heartbeats)
- Participants with following measurements indicative of hepatic or renal impairment during the pre-treatment observation period: Aspartate transaminase (AST) greater than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5 times the upper limit of reference range, serum creatinine greater than 3 times the upper limit of reference range
- Participants with any cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance
Data sourced from ClinicalTrials.gov (NCT00644787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.