TK-FT Phase 2 Study (Efficacy and Safety Study)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220503

Enrollment

Registered

2008-01-15

Start date

2008-01-15

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

Breakthrough cancer pain

Interventions

investigational material(s) Generic name etc : TK-FT (Fentanyl TAIFUN) INN of investigational material : Fentanyl Citrate Therapeutic category code : 821 Synthetic narcotics Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who were diagnosed with cancer 2)Patients who are 20-74 years old at the time of informed consent 3)Patients who are managed with opioid maintenance therapy for persistent cancer pain 4)Patients who are managed with rescue opioid for breakthrough cancer pain etc.

Exclusion criteria

Exclusion criteria: 1)Patients with uncontrolled or rapidly increasing cancer pain 2)Patients with organic encephalopathies such as intracranial hypertension, consciousness disturbed, coma or brain tumour 3)Patients with history of convulsive seizure 4)Patients with asthma etc.

Design outcomes

Primary

Measure	Time frame
Efficacy and Safety	—

Outcome results

None listed

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