NCT05813847CompletedPhase 3
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
Cali Pharmaceuticals LLC1 site in 1 country518 target enrollmentStarted: April 18, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cali Pharmaceuticals LLC
- Enrollment
- 518
- Locations
- 1
- Primary Endpoint
- Pain control
Study Overview
Brief Summary
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to sign Informed Consent
- •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
- •Previously inguinal herniorrhaphy
- •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.
Arms & Interventions
Ropivacaine HCl
Active Comparator
Local infiltration of Naropin
Intervention: local anaesthetic injection (Drug)
Placebo
Placebo Comparator
Local infiltration of Saline Placebo
Intervention: local anaesthetic injection (Drug)
CPL-01
Experimental
Local infiltration of CPL-01
Intervention: local anaesthetic injection (Drug)
Outcomes
Primary Outcomes
Pain control
Time Frame: 72 hours
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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