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Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PBK_L1704 0.35mg
PBK_L1704 0.5mg
Placebo
Sponsored by
Pharmbio Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation
  • Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.

Exclusion Criteria:

  • Participated in another oliceridine clinical study.
  • Received any investigational drug, device or therapy within 35 days before surgery.
  • Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.
  • American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.

Sites / Locations

  • Seoul Asan medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PBK_L1704 0.35mg

PBK_L1704 0.5mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

SPID-48
Sum of Pain Intensity Differences (SPID) from baseline to 48 hours

Secondary Outcome Measures

Responder rate
A patient is a responder if their final time-weighted Sum of Pain Intensity Differences from baseline (SPID-48) corresponds to, or is greater than, a 30% improvement.
Time to rescue pain medication use
Proportion of rescue pain medication use
Total rescue pain medication use

Full Information

First Posted
August 19, 2022
Last Updated
August 19, 2022
Sponsor
Pharmbio Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05509868
Brief Title
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
December 26, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmbio Korea Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PBK_L1704 0.35mg
Arm Type
Experimental
Arm Title
PBK_L1704 0.5mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PBK_L1704 0.35mg
Intervention Description
The subject will receive PBK_L1704 0.35mg/ml by PCA
Intervention Type
Drug
Intervention Name(s)
PBK_L1704 0.5mg
Intervention Description
The subject will receive PBK_L1704 0.5mg/ml by PCA
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The subject will receive placebo by PCA
Primary Outcome Measure Information:
Title
SPID-48
Description
Sum of Pain Intensity Differences (SPID) from baseline to 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Responder rate
Description
A patient is a responder if their final time-weighted Sum of Pain Intensity Differences from baseline (SPID-48) corresponds to, or is greater than, a 30% improvement.
Time Frame
48 hours
Title
Time to rescue pain medication use
Time Frame
48 hours
Title
Proportion of rescue pain medication use
Time Frame
48 hours
Title
Total rescue pain medication use
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure. Exclusion Criteria: Participated in another oliceridine clinical study. Received any investigational drug, device or therapy within 35 days before surgery. Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study. American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager Clinical Trial team, Pharmbio Korea
Phone
+82-2-587-2551
Email
cr@pharmbio.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee
Organizational Affiliation
Seoul Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Asan medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee

12. IPD Sharing Statement

Learn more about this trial

Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

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