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

Sponsor
Pharmbio Korea Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05509868
Collaborator
(none)
225
Enrollment
1
Location
3
Arms
5.4
Anticipated Duration (Months)
42
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PBK_L1704 0.35mg
  • Drug: PBK_L1704 0.5mg
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Dec 26, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PBK_L1704 0.35mg

Drug: PBK_L1704 0.35mg
The subject will receive PBK_L1704 0.35mg/ml by PCA
Experimental: PBK_L1704 0.5mg

Drug: PBK_L1704 0.5mg
The subject will receive PBK_L1704 0.5mg/ml by PCA
Placebo Comparator: Placebo

Drug: Placebo
The subject will receive placebo by PCA

Outcome Measures

Primary Outcome Measures

  1. SPID-48 [48 hours]

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

Secondary Outcome Measures

  1. Responder rate [48 hours]

    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.

  2. Time to rescue pain medication use [48 hours]

  3. Proportion of rescue pain medication use [48 hours]

  4. Total rescue pain medication use [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul Asan medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Pharmbio Korea Co., Ltd.

Investigators

  • Principal Investigator: Lee, Seoul Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pharmbio Korea Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05509868
Other Study ID Numbers:
  • PBK_L1704_301
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Pain

Study Results

No Results Posted as of Aug 22, 2022