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

Phase 3

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: SyB P-1501 placebo; Drug: SyB P-1501

• Registration Number: NCT03005899
• Lead Sponsor: SymBio Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-10
• Study Start: 2016-11-21
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Primary Completion: 2017-07-21
• Study Completion: 2017-07-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SyB P-1501 placebo 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.
SyB P-1501 group	SyB P-1501	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.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products	20 days	Presence or absence and evaluation of technical failures
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application	0 to 24 hours	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
Proportion of dropouts for any reason during the period between Hour 3 and Hour 24 of system application or between the system application and Hour 24	0 to 24 hours	Proportion of dropouts for any reason during the period between Hour 3 and Hour 24 of system application will be evaluated.; Proportion of dropouts for any reason between the system application and Hour 24 will be also evaluated.
Patient global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups	0 to 24 hours	Patient global assessment of therapeutic effect at the end of Hour 24 or when the study treatment is discontinued will be evaluated on a categorical scale
Investigator global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups	0 to 24 hours	Investigator global assessment of therapeutic effect at the end of Hour 24 or when the study treatment is discontinued will be evaluated on a categorical scale
time to dropout during the period between Hour 3 and Hour 24 of system application (Non-dropout: censored at 24 hours after application) or from application (Non-dropout: censored at 24 hours after application)	0 to 24 hours	Time to dropout during the period between Hour 3 and Hour 24 of system application will be evaluated (Non-dropout: censored at 24 hours after application).; Time to dropout from application will be also evaluated (Non-dropout: censored at 24 hours after application)
pain intensity（Numerical rating scale: NRS） expressed as a mean for each group and compared using Student t test between groups	0 to 72 hours	During the pre-treatment period, up to Hour 24 of the treatment period, and at the time of removing each patch, pain intensity at the time of each measurement will be evaluated as NRS
Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level	20 days	Adverse event evaluation (including application site erythema and other application site reaction)
Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test) measured with descriptive statistics	20 days	Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Wakayama, Japan