Clinical trial · Interventional
A Comparative Study of KW-2246
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
NCT01326689CI-TRIAL-000263472246-004completedPhase 3ClinicalTrials.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)
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.
Conditions
Conditions (1)
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 Related Pain (Breakthrough Pain) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KW-2246 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KW-2246
- interventionNames
- Drug: KW-2246
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Pain intensity difference
- timeFrame
- 30 minutes after each dose
- description
- Pain scores on the visual analog scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose * Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled * ECOG PS =\< 3 Exclusion Criteria: * Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics * Severe respiratory dysfunction * Asthma * Severe bradyarrhythmia * Severe hepatic function disorder * Severe renal function disorder * Severe psychoneurotic disorder * Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
References
Publications (1)
- DERIVEDShimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20. PMID 24839047