Title
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
Phase
Phase 3Lead Sponsor
SymBio PharmaceuticalsStudy Type
InterventionalStatus
TerminatedIndication/Condition
Postoperative PainIntervention/Treatment
fentanyl ...Study Participants
49This 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.
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
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.
One patch of SyB P-1501 contains 10.8 mg of fentanyl hydrochloride (fentanyl 9.7 mg) and produces an electric current to deliver the drug iontophoretically after the system is activated. 40 µg fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours or maximum of 80 doses. Each system will inactivate at 80 doses or 24 hours, whichever occurs first.
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.
Patients who meet all of the inclusion criteria from the day of informed consent to one day before surgery and to whom none of the exclusion criteria is applicable will be eligible to participate in the study. Inclusion Criteria: Expected to require opioid analgesia for management of post-operative pain for at least 24 hours after surgery and require postoperative pain control Underwent one of the following surgeries under general anesthesia: Abdominal surgery (e.g., gastrointestinal, gynecological) Orthopedic surgery (e.g., spinal surgery) Thoracic surgery (e.g., respiratory surgery not requiring chest tubes after surgery) ASA physical status I, II or III Age: At least 20 years Sex: Men or women (negative pregnancy test for women of childbearing potential). Inpatient/outpatient status: Inpatient Received adequate information about the study and gave a written consent to participate in the study by himself/herself Exclusion Criteria: Expected to use continuous intra-operative and post-operative analgesia with local pain control techniques (e.g., spinal/epidural analgesia, nerve block) Scheduled for body surface surgery (e.g., burn, breast reconstruction, skin grafting) Hypersensitive/allergic to fentanyl, skin adhesive and/or cetylpyridinium chloride Expected/scheduled to undergo additional surgical procedure within 36 hours post-operation Known or suspected opioid tolerance Skin disorder that precludes application of investigational product Increased intracranial pressure Concomitant asthma, severe respiratory disorder Having had convulsive seizure attacks within 5 years Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators History of opioid, drug and/or alcohol abuse Women who are pregnant, might be pregnant, or are breastfeeding Using any investigational drug, used any investigational drug within the last 6 months Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator
