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

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Collaborator: Yutoku Pharmaceutical
• Treatments: Fentanyl

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