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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RECRUITING
PHASE3
504 participants
INTERVENTIONAL
2023-04-18
2024-12-31
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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CPL-01
Local infiltration of CPL-01
local anaesthetic injection
Local infiltration of study drug
Ropivacaine HCl
Local infiltration of Naropin
local anaesthetic injection
Local infiltration of study drug
Placebo
Local infiltration of Saline Placebo
local anaesthetic injection
Local infiltration of study drug
Interventions
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local anaesthetic injection
Local infiltration of study drug
Eligibility Criteria
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Inclusion Criteria
* Scheduled to have inguinal hernia repair
* Be a reasonably healthy adult 18 - 75 years of age
* Body mass index ≤ 39 kg/m2
* If biologically female, not pregnant or planning to become pregnant
* If biologically male, using acceptable birth control
* Be willing and able to complete study procedures
Exclusion Criteria
* Concurrent painful condition that may require analgesic treatment
* History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
* Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
* History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
* Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Malignancy in the past year
* Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
18 Years
75 Years
ALL
No
Sponsors
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Cali Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Erol Onel
Role: STUDY_DIRECTOR
Cali Biosciences
Locations
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Todd Bertoch
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Todd Bertoch
Role: primary
Other Identifiers
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CPL-01-301
Identifier Type: -
Identifier Source: org_study_id
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