Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
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ClinicalTrials.gov Identifier: NCT04203537 |
Recruitment Status :
Completed
First Posted : December 18, 2019
Results First Posted : January 12, 2022
Last Update Posted : May 8, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postsurgical Pain | Drug: CA-008 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 193 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 4, 2019 |
Actual Primary Completion Date : | October 26, 2020 |
Actual Study Completion Date : | October 26, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: CA-008 36 mg
Single administration (0.3 mg/mL concentration)
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Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin |
Active Comparator: CA-008 60 mg
Single administration (0.5 mg/mL concentration)
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Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin |
Active Comparator: CA-008 90 mg
Single administration (0.75 mg/mL concentration)
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Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin |
Placebo Comparator: Placebo
Single administration
|
Drug: Placebo
Local administration during surgery |
- Pain Intensity Scores [ Time Frame: 0 to Day 15 post dose ]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
- Total Opioid Consumption [ Time Frame: 0 to Day 15 post dose ]CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203537
United States, California | |
Lotus Clinical Reserach, LLC | |
Pasadena, California, United States, 91105 | |
United States, Texas | |
Legent Orthopedic Hospital | |
Carrollton, Texas, United States, 75006 | |
First Surgical Hospital | |
Houston, Texas, United States, 77401 | |
Plano Surgical Hospital | |
Plano, Texas, United States, 75093 |
Principal Investigator: | Daneshvari Solanki, MD | HD Research |
Documents provided by Concentric Analgesics:
Responsible Party: | Concentric Analgesics |
ClinicalTrials.gov Identifier: | NCT04203537 |
Other Study ID Numbers: |
CA-PS-208 |
First Posted: | December 18, 2019 Key Record Dates |
Results First Posted: | January 12, 2022 |
Last Update Posted: | May 8, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |