TK-FT Pharmacokinetic Study (Patients)

Phase 1

• Conditions: Breakthrough cancer pain

• Registration Number: JPRN-jRCT2080220502
• Lead Sponsor: TEIKOKU SEIYAKU CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 15

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified