NCT03005899

Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain

Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	SyB P-1501	After extubation and adequate titration by Fentanyl intravenous injection, the investigational product is applied to outer upper arm or chest on patient who confirmed treatment eligibility. Fentanyl 40 μg per dose is delivered over a 10-minute period by pressing the dosing button by the subject as needed. The 10-minute dosing period is a system lock-out time, allowing for a maximum of 6 doses per hour. One system is operable for 24 hours or until 80 doses are delivered, whichever occurs first. Duration of application of the investigational product is 24 hours. Duration of application may be extended for up to 72 hours or until the third system is used, whichever occurs first, if the patient requests it and the specified tests can be performed
DRUG	SyB P-1501 placebo	Identical to SyB P-1501 containing hydrogel that contains the active ingredient fentanyl HCI in its structure and appearance but production of an electric current and subsequent drug administration by iontophoresis are prevented because of its modified circuit.

Timeline

• Start date: 2016-11-21
• Primary completion: 2017-07-21
• Completion: 2017-07-21
• First posted: 2016-12-30
• Last updated: 2022-11-17

Locations

29 sites across 1 country: Japan