Postsurgical Pain Clinical Trial
Official title:
A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy
Verified date | April 2024 |
Source | Concentric Analgesics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
Status | Completed |
Enrollment | 193 |
Est. completion date | October 26, 2020 |
Est. primary completion date | October 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia - Aged 18-80 years old - ASA physical class 1, 2, or 3 - BMI </= 42 kg/m2 - Generally healthy Exclusion Criteria: - Concurrent condition requiring analgesic treatment during study period - Opioid tolerant - Known allergy to capsaicin or other study medication - Use of prohibited medications |
Country | Name | City | State |
---|---|---|---|
United States | Legent Orthopedic Hospital | Carrollton | Texas |
United States | First Surgical Hospital | Houston | Texas |
United States | Lotus Clinical Reserach, LLC | Pasadena | California |
United States | Plano Surgical Hospital | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Concentric Analgesics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity Scores | Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15 | 0 to Day 15 post dose | |
Secondary | Total Opioid Consumption | CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents | 0 to Day 15 post dose |
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