Clinical trial

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

Name

2015002

Description

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.

Trial arms

Trial start

2016-11-21

Estimated PCD

2017-07-21

Trial end

2017-07-21

Status

Terminated

Phase

Early phase I

Treatment

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

Arms:

SyB P-1501 group

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.

Arms:

SyB P-1501 placebo group

Size

Primary endpoint

Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application

3 to 24 hours

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: 1. Expected to require opioid analgesia for management of post-operative pain for at least 24 hours after surgery and require postoperative pain control 2. 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) 3. ASA physical status I, II or III 4. Age: At least 20 years 5. Sex: Men or women (negative pregnancy test for women of childbearing potential). 6. Inpatient/outpatient status: Inpatient 7. Received adequate information about the study and gave a written consent to participate in the study by himself/herself Exclusion Criteria: 1. Expected to use continuous intra-operative and post-operative analgesia with local pain control techniques (e.g., spinal/epidural analgesia, nerve block) 2. Scheduled for body surface surgery (e.g., burn, breast reconstruction, skin grafting) 3. Hypersensitive/allergic to fentanyl, skin adhesive and/or cetylpyridinium chloride 4. Expected/scheduled to undergo additional surgical procedure within 36 hours post-operation 5. Known or suspected opioid tolerance 6. Skin disorder that precludes application of investigational product 7. Increased intracranial pressure 8. Concomitant asthma, severe respiratory disorder 9. Having had convulsive seizure attacks within 5 years 10. Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators 11. History of opioid, drug and/or alcohol abuse 12. Women who are pregnant, might be pregnant, or are breastfeeding 13. Using any investigational drug, used any investigational drug within the last 6 months 14. Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

Updated at

2022-11-17

1 organization

1 product

1 indication

Product

SyB P-1501

Indication

Postoperative Pain

Organization

SymBio Pharmaceuticals