Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
NCT ID: NCT05509868
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
225 participants
INTERVENTIONAL
2022-07-20
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PBK_L1704 0.35mg
PBK_L1704 0.35mg
The subject will receive PBK\_L1704 0.35mg/ml by PCA
PBK_L1704 0.5mg
PBK_L1704 0.5mg
The subject will receive PBK\_L1704 0.5mg/ml by PCA
Placebo
Placebo
The subject will receive placebo by PCA
Interventions
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PBK_L1704 0.35mg
The subject will receive PBK\_L1704 0.35mg/ml by PCA
PBK_L1704 0.5mg
The subject will receive PBK\_L1704 0.5mg/ml by PCA
Placebo
The subject will receive placebo by PCA
Eligibility Criteria
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Inclusion Criteria
* Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.
Exclusion Criteria
* 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.
19 Years
75 Years
ALL
No
Sponsors
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Pharmbio Korea Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lee
Role: PRINCIPAL_INVESTIGATOR
Seoul Asan Medical Center
Locations
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Seoul Asan medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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PBK_L1704_301
Identifier Type: -
Identifier Source: org_study_id
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