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

November 14, 2022 updated by: SymBio Pharmaceuticals

Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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
        • Research Site
    • Aichi
      • Nagakute, Aichi, Japan
        • Research Site
      • Nagoya, Aichi, Japan
        • Research Site
      • Toyoake, Aichi, Japan
        • Research Site
    • Hyogo
      • Kobe, Hyogo, Japan
        • Research Site
    • Ishikawa
      • Kahoku, Ishikawa, Japan
        • Research Site
      • Kanazawa, Ishikawa, Japan
        • Research Site
    • Kagawa
      • Miki, Kagawa, Japan
        • Research Site
    • Kochi
      • Nankoku, Kochi, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Nagano
      • Matsumoto, Nagano, Japan
        • Research Site
    • Nara
      • Kashihara, Nara, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Osaka
      • Osakasayama, Osaka, Japan
        • Research Site
      • Suita, Osaka, Japan
        • Research Site
      • Takatsuki, Osaka, Japan
        • Research Site
    • Shimane
      • Izumo, Shimane, Japan
        • Research Site
    • Tokyo
      • Arakawa, Tokyo, Japan
        • Research Site
      • Minato, Tokyo, Japan
        • Research Site
    • Tottori
      • Yonago, Tottori, Japan
        • Research Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan
        • Research Site
    • Yamanashi
      • Chuo, Yamanashi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SyB P-1501 group
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.
Drug: SyB P-1501

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
Placebo Comparator: SyB P-1501 placebo group
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application
Time Frame: 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
3 to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application
Time Frame: 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
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)
Time Frame: 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)
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
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
0 to 24 hours
Investigator global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
Time Frame: 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
0 to 24 hours
Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level
Time Frame: 20 days
Adverse event evaluation (including application site erythema and other application site reaction)
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) measured with descriptive statistics
Time Frame: 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)
20 days
incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products
Time Frame: 20 days
Presence or absence and evaluation of technical failures
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SymBio Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Takayuki Kawashima, SymBio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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