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

NCT ID: NCT03005899

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-21
• Study Completion Date: 2017-07-21

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

SyB P-1501

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

SyB P-1501 placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takayuki Kawashima

Role: STUDY_DIRECTOR

SymBio Pharmaceuticals

Locations

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

Countries

Japan

Other Identifiers

2015002

Identifier Type: -

Identifier Source: org_study_id