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

NCT03005899 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-11-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • SymBio Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Takayuki Kawashima · SymBio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2017-07-21
Completion
2017-07-21

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005899 on ClinicalTrials.gov