Clinical trial NCT03005899: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
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
timeFrame: 3 to 24 hours
Secondary outcomes:
measure: Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application
timeFrame: 0 to 24 hours
measure: 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)
timeFrame: 0 to 24 hours
measure: 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
timeFrame: 0 to 24 hours
measure: pain intensity（Numerical rating scale: NRS） expressed as a mean for each group and compared using Student t test between groups
timeFrame: 0 to 72 hours
measure: Patient global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
timeFrame: 0 to 24 hours
measure: Investigator global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups
timeFrame: 0 to 24 hours
measure: Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level
timeFrame: 20 days
measure: 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
timeFrame: 20 days
measure: incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products
timeFrame: 20 days
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Research Site
state: Aichi
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Toyoake
country: Japan
facility: Research Site
state: Aichi
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kahoku
country: Japan
facility: Research Site
state: Ishikawa
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Miki
country: Japan
facility: Research Site
state: Kagawa
city: Nankoku
country: Japan
facility: Research Site
state: Kochi
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Kashihara
country: Japan
facility: Research Site
state: Nara
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki
country: Japan
facility: Research Site
state: Osaka
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Arakawa
country: Japan
facility: Research Site
state: Tokyo
city: Minato
country: Japan
facility: Research Site
state: Tokyo
city: Yonago
country: Japan
facility: Research Site
state: Tottori
city: Ube
country: Japan
facility: Research Site
state: Yamaguchi
city: Chuo
country: Japan
facility: Research Site
state: Yamanashi
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
Study officials:
affiliation: SymBio Pharmaceuticals
name: Takayuki Kawashima
role: STUDY_DIRECTOR
References: