Back to resultsStudy of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SyB P-1501
SyB P-1501 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
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:
- 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
Exclusion Criteria:
- 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
- Skin disorder that precludes application of investigational product
- Increased intracranial pressure
- Concomitant asthma, severe respiratory disorder
- Having had convulsive seizure attacks within 5 years
- Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators
- History of opioid, drug and/or alcohol abuse
- Women who are pregnant, might be pregnant, or are breastfeeding
- Using any investigational drug, used any investigational drug within the last 6 months
- Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SyB P-1501 group
SyB P-1501 placebo group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application
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
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)
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)
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
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.
pain intensity（Numerical rating scale: NRS） expressed as a mean for each group and compared using Student t test between groups
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
Patient global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
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
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
Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level
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
Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test)
incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products
Presence or absence and evaluation of technical failures
Full Information
NCT ID
NCT03005899
First Posted
November 10, 2016
Last Updated
November 14, 2022
Sponsor
SymBio Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03005899
Brief Title
Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
Official Title
Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymBio Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SyB P-1501 group
Arm Type
Experimental
Arm 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.
Arm Title
SyB P-1501 placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
SyB P-1501
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SyB P-1501 placebo
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application
Description
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
Time Frame
3 to 24 hours
Secondary Outcome Measure Information:
Title
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application
Description
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
Time Frame
0 to 24 hours
Title
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)
Description
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)
Time Frame
0 to 24 hours
Title
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
Description
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.
Time Frame
0 to 24 hours
Title
pain intensity（Numerical rating scale: NRS） expressed as a mean for each group and compared using Student t test between groups
Description
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
Time Frame
0 to 72 hours
Title
Patient global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
Description
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
Time Frame
0 to 24 hours
Title
Investigator global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
Description
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 Frame
0 to 24 hours
Title
Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level
Description
Adverse event evaluation (including application site erythema and other application site reaction)
Time Frame
20 days
Title
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
Description
Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test)
Time Frame
20 days
Title
incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products
Description
Presence or absence and evaluation of technical failures
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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:
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
Exclusion Criteria:
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
Skin disorder that precludes application of investigational product
Increased intracranial pressure
Concomitant asthma, severe respiratory disorder
Having had convulsive seizure attacks within 5 years
Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators
History of opioid, drug and/or alcohol abuse
Women who are pregnant, might be pregnant, or are breastfeeding
Using any investigational drug, used any investigational drug within the last 6 months
Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takayuki Kawashima
Organizational Affiliation
SymBio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nagakute
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyoake
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kahoku
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Miki
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Nankoku
State/Province
Kochi
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Research Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Takatsuki
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Izumo
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Yonago
State/Province
Tottori
Country
Japan
Facility Name
Research Site
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Yamanashi
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Fukushima
Country
Japan
Facility Name
Research Site
City
Kagoshima
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Saga
Country
Japan
Facility Name
Research Site
City
Tokushima
Country
Japan
Facility Name
Research Site
City
Wakayama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
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