Study of SyB P-1501 (Fentanyl HCI) for Treatment of Posto... | NCT03005899

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SyB P-1501 group	Experimental	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.	Drug: SyB P-1501
SyB P-1501 placebo group	Placebo Comparator	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.	Drug: SyB P-1501 placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SyB P-1501	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application	proportion of dropouts due to inadequate analgesia during the period between Hour 3 and Hour 24 of system application. Inadequate analgesia cases are defined below. The subject wishes to discontinue the study due to inadequate analgesia Investigator or sub-investigator judges that the patient is to be discontinued due to inadequate analgesia The subject who completes 80 doses within 24 hours is not willing to use the second system and wishes an alternative analgesia	3 to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application	Proportion of dropouts due to inadequate analgesia during the period between the start and Hour 24 of system application. Inadequate analgesia cases are defined below. The subject wishes to discontinue the study due to inadequate analgesia Investigator or sub-investigator judges that the patient is to be discontinued due to inadequate analgesia The subject who completes 80 doses within 24 hours is not willing to use the second system and wishes an alternative analgesia

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Nagakute	Aichi-ken		Japan
Research Site

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms