Study Stopped
Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.
Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
1 other identifier
interventional
49
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Nov 2016
Shorter than P25 for phase_3 postoperative-pain
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2016
CompletedStudy Start
First participant enrolled
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2017
CompletedNovember 17, 2022
November 1, 2022
8 months
November 10, 2016
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 (9)
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
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
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
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
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
- +4 more secondary outcomes
Study Arms (2)
SyB P-1501 group
EXPERIMENTALOne 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.
SyB P-1501 placebo group
PLACEBO COMPARATORIdentical 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.
Interventions
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
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.
Eligibility Criteria
You may not qualify if:
- 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
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Research Site
Nagakute, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Toyoake, Aichi-ken, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kahoku, Ishikawa-ken, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Hiragi, Kagawa-ken, Japan
Research Site
Nankoku, Kochi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Kashihara, Nara, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Takatsuki, Osaka, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Arakawa City, Tokyo, Japan
Research Site
Minato, Tokyo, Japan
Research Site
Yonago, Tottori, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Chūō, Yamanashi, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Kagoshima, Japan
Research Site
Kyoto, Japan
Research Site
Okayama, Japan
Research Site
Saga, Japan
Research Site
Tokushima, Japan
Research Site
Wakayama, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takayuki Kawashima
SymBio Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
December 30, 2016
Study Start
November 21, 2016
Primary Completion
July 21, 2017
Study Completion
July 21, 2017
Last Updated
November 17, 2022
Record last verified: 2022-11