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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03005899
• Other study ID #: 2015002
• Status: Terminated
• Phase: Phase 3
• Start date: November 21, 2016
• Est. completion date: July 21, 2017

Study information

• Verified date: November 2022
• Source: SymBio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: July 21, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Japan	Research Site	Arakawa	Tokyo
Japan	Research Site	Chuo	Yamanashi
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Izumo	Shimane
Japan	Research Site	Kagoshima
Japan	Research Site	Kahoku	Ishikawa
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Kashihara	Nara
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kurashiki	Okayama
Japan	Research Site	Kyoto
Japan	Research Site	Matsumoto	Nagano
Japan	Research Site	Miki	Kagawa
Japan	Research Site	Minato	Tokyo
Japan	Research Site	Nagakute	Aichi
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Nankoku	Kochi
Japan	Research Site	Okayama
Japan	Research Site	Osakasayama	Osaka
Japan	Research Site	Saga
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Suita	Osaka
Japan	Research Site	Takatsuki	Osaka
Japan	Research Site	Tokushima
Japan	Research Site	Toyoake	Aichi
Japan	Research Site	Ube	Yamaguchi
Japan	Research Site	Wakayama
Japan	Research Site	Yonago	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	0 to 24 hours
Secondary	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)	0 to 24 hours
Secondary	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.	0 to 24 hours
Secondary	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	0 to 72 hours
Secondary	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	0 to 24 hours
Secondary	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	0 to 24 hours
Secondary	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)	20 days
Secondary	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)	20 days
Secondary	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	20 days