Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
NCT ID: NCT04203537
Last Updated: 2024-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
193 participants
INTERVENTIONAL
2019-12-04
2020-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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CA-008 36 mg
Single administration (0.3 mg/mL concentration)
CA-008
Local administration during surgery
CA-008 60 mg
Single administration (0.5 mg/mL concentration)
CA-008
Local administration during surgery
CA-008 90 mg
Single administration (0.75 mg/mL concentration)
CA-008
Local administration during surgery
Placebo
Single administration
Placebo
Local administration during surgery
Interventions
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CA-008
Local administration during surgery
Placebo
Local administration during surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18-80 years old
* ASA physical class 1, 2, or 3
* BMI \</= 42 kg/m2
* Generally healthy
Exclusion Criteria
* Opioid tolerant
* Known allergy to capsaicin or other study medication
* Use of prohibited medications
18 Years
80 Years
ALL
No
Sponsors
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Concentric Analgesics
INDUSTRY
Responsible Party
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Principal Investigators
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Daneshvari Solanki, MD
Role: PRINCIPAL_INVESTIGATOR
HD Research
Locations
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Lotus Clinical Reserach, LLC
Pasadena, California, United States
Legent Orthopedic Hospital
Carrollton, Texas, United States
First Surgical Hospital
Houston, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CA-PS-208
Identifier Type: -
Identifier Source: org_study_id
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