Skip to content

TK-FT Pharmacokinetic Study (Patients)

TK-FT Pharmacokinetic Study (Patients)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220502
Enrollment
15
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

Sponsors

TEIKOKU SEIYAKU CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who were diagnosed with cancer 2)Patients who were diagnosed as 0-2 by PS (ECOG Performance Status) 3)Patients who are 20-74 years old at the time of informed consent 4)Patients who are managed with opioid maintenance therapy for persistent cancer pain 5)Patients who are managed with rescue opioid for breakthrough cancer pain etc.

Exclusion criteria

Exclusion criteria: 1)Patients with intolerance or history of previous allergies or sensitivity to fentanyl citrate, fentanyl or lactose 2)Patients with lung cancer 3)Patients with buccal, nasal or gastrointestinal cancer 4)Patients with history of buccal, nasal, pulmonary or gastro-intestinal disorders which in the opinion of the investigating physician will affect the absorption of study drug 5)Patients with organic encephalopathies such as intracranial hypertension, consciousness disturbed, coma or brain tumour 6)Patients with history of convulsive seizure 7)Patients with renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction , and with evidence of them 8)Patients with asthma etc.

Outcome results

None listed

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