Clinical trial · Interventional
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics
NCT00644787CI-TRIAL-00010702completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl 1-day transdermal patch (Double Blind Phase) | Drug | — | UNRESOLVED |
| Fentanyl 1-day transdermal patch (Titration Phase) | Drug | — | UNRESOLVED |
| Fentanyl 3-day transdermal patch (Double Blind Phase) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Fentanyl 1-day transdermal patch (Titration Phase)
- description
- Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase.
- interventionNames
- Drug: Fentanyl 1-day transdermal patch (Titration Phase)
- type
- EXPERIMENTAL
- label
- Fentanyl 1-day transdermal patch (Double Blind Phase)
- description
- Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.