Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

Concentric Analgesics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postsurgical Pain

Treatments: Drug: Placebo; Drug: CA-008

Study type: Interventional

Funder types: Industry

Identifiers

NCT04203537

CA-PS-208

Details and patient eligibility

About

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.

Full description

Not provided

Enrollment: 193 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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193 participants in 4 patient groups, including a placebo group

CA-008 36 mg

Active Comparator group

Description:

Single administration (0.3 mg/mL concentration)

Treatment:

Drug: CA-008

CA-008 60 mg

Active Comparator group

Description:

Single administration (0.5 mg/mL concentration)

Treatment:

Drug: CA-008

CA-008 90 mg

Active Comparator group

Description:

Single administration (0.75 mg/mL concentration)

Treatment:

Drug: CA-008

Placebo

Placebo Comparator group

Description:

Single administration

Treatment:

Drug: Placebo