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

SymBio Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: SyB P-1501 placebo; Drug: SyB P-1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT03005899

2015002

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

SyB P-1501 group

Experimental group

Description:

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.

Treatment:

Drug: SyB P-1501

SyB P-1501 placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: SyB P-1501 placebo