Phase III study of HFT-290

Phase 3

Completed

• Conditions: Cancer pain

• Registration Number: JPRN-jRCT2080223853
• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Brief Summary

Cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to HFT-290 for 2 weeks. Serum fentanyl concentration was measured at steady state. A total of 11 patients were enrolled. No patient received a dose exceeding 2 mg. Mean serum fentanyl concentrations after administration of 0.5, 1, and 2 mg were 144 (n = 4), 277 (n = 3), and 2070 pg/mL (n = 4), respectively. No respiratory adverse events were observed, and pain was well controlled.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-02
• Study Completion: 2019-11-13
• Results First Posted: 2021-11-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Pediatric patients confirmed to have various types of cancer.

Exclusion Criteria

- Patients with any cutaneous abnormalities at the planned application site that could be aggravated by application of the investigational product.
- Patients with serious cardiac, hepatic, or renal dysfunction, serious respiratory disorders, or severe respiratory depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>pharmacokinetics<br>pharmacokinetics, safety

Secondary Outcome Measures

Name	Time	Method
efficacy<br>efficacy