FindTrial
Sign In

A phase III 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)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221423
Enrollment
Unknown
Registered
2011-03-30
Start date
2011-03-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer related pain (breakthrough pain)

Interventions

investigational material(s) Generic name etc : KW-2246 INN of investigational material : fentanyl Therapeutic category code : 821 Synthetic narcotics Dosage and Administration for Investigational mate

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics - Ssevere 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

Design outcomes

Primary

MeasureTime frame
Efficacy: Pain intensity difference—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026