Postoperative PainPhase 3NCT03005899
Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
A Phase 3 study testing SyB P-1501 in people with Postoperative Pain, run by SymBio Pharmaceuticals at 29 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SyB P-1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 29 sitesJapan
- Study dates
- 21 Nov 2016to 21 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Research Site
Arakawa City, Tokyo
Research Site
Chūō, Yamanashi
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Hiragi, Kagawa-ken
Research Site
Izumo, Shimane
Research Site
Kagoshima
Research Site
Kahoku, Ishikawa-ken
Research Site
Kanazawa, Ishikawa-ken
Research Site
Kashihara, Nara
Research Site
Kobe, Hyōgo
Research Site
Kurashiki, Okayama-ken
Research Site
Kyoto
Research Site
Matsumoto, Nagano
Research Site
Minato, Tokyo
Research Site
Nagakute, Aichi-ken
Research Site
Nagoya, Aichi-ken
Research Site
Nankoku, Kochi
Research Site
Okayama
Research Site
Saga
Research Site
Sayama, Osaka
Research Site
Sendai, Miyagi
Research Site
Suita, Osaka
Research Site
Takatsuki, Osaka
Research Site
Tokushima
Research Site
Toyoake, Aichi-ken
Research Site
Ube, Yamaguchi
Research Site
Wakayama
Research Site
Yonago, Tottori
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- SyB P-1501, SyB P-1501 placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyB P-1501Drug
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
SyB P-1501 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SyB P-1501 group | Experimental | 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. Receives: Drug: SyB P-1501 |
| SyB P-1501 placebo group | Placebo comparator | 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. Receives: Drug: SyB P-1501 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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 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)
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
Adverse event evaluation (including application site erythema and other application site reaction)
Measured: 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
Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test)
Measured: 20 days
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
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start21 Nov 2016
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
Why it stopped: Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takayuki Kawashima, Study director, SymBio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005899
- Sponsor's protocol ID
- 2015002
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2016
- Last updated
- 17 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
- ClinicalTrials.gov ID
- NCT03005899
- Acronym / sponsor ID
- 2015002
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SyB P-1501 group | Experimental | Drug: SyB P-1501One 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 comparator | Drug: SyB P-1501 placeboIdentical 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- ASA physical status I, II or III
- Age: At least 20 years
- Sex: Men or women (negative pregnancy test for women of childbearing potential).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyB P-1501After 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 | Drug | SyB P-1501 group |
| SyB P-1501 placeboIdentical 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 group |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study was stopped early (reason given: Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takayuki Kawashima study director
SymBio Pharmaceuticals
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SyB P-1501 in people with Postoperative Pain, run by SymBio Pharmaceuticals at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Clinical trial was terminated due to discontinuation of drug product by the investigational drug supplier.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.