Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
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ClinicalTrials.gov Identifier: NCT04774328 |
Recruitment Status :
Completed
First Posted : March 1, 2021
Results First Posted : September 14, 2022
Last Update Posted : September 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postsurgical Pain | Drug: CA-008 (vocacapsaicin) Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair |
Actual Study Start Date : | September 9, 2020 |
Actual Primary Completion Date : | June 15, 2021 |
Actual Study Completion Date : | June 15, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: CA-008 (vocacapsaicin)
Single administration
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Drug: CA-008 (vocacapsaicin)
Single administration of CA-008 (vocacapsaicin) versus placebo |
Placebo Comparator: Placebo
Single administration
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Drug: Placebo
Single administration of CA-008 (vocacapsaicin) versus placebo |
- Pain at Rest - Part B [ Time Frame: Up to 96 hours ]Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
- Evoked NRS - Part B [ Time Frame: Up to 96 hours ]
Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h).
NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
- Opioid Consumption - Part B [ Time Frame: Up to Day 8 ]Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).
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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, primary, open laparotomy with VHR, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction
- ASA physical class 1, 2, or 3
- BMI </= 40 kg/m2
- Aged 18-80 years old
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): NCT04774328
United States, Texas | |
First Surgical Hospital | |
Houston, Texas, United States, 77004 |
Principal Investigator: | Daneshvari Solanki, MD | First Surgical Hospital |
Documents provided by Concentric Analgesics:
Responsible Party: | Concentric Analgesics |
ClinicalTrials.gov Identifier: | NCT04774328 |
Other Study ID Numbers: |
CA-PS-209 |
First Posted: | March 1, 2021 Key Record Dates |
Results First Posted: | September 14, 2022 |
Last Update Posted: | September 14, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hernia, Ventral Pain, Postoperative Hernia Pathological Conditions, Anatomical Hernia, Abdominal |
Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |