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Open-Label CA-008 in Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03885596
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
Concentric Analgesics

Brief Summary:
A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Condition or disease Intervention/treatment Phase
Pain Drug: CA-008 Phase 2

Detailed Description:
This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : October 22, 2019

Arm Intervention/treatment
Experimental: Open-Label CA-008
CA-008 4.2 mg reconstituted in saline
Drug: CA-008
Drug: CA-008 4.2 mg reconstituted in saline

Primary Outcome Measures :
  1. Time-specific mean pain intensity scores Numerical Rating Scale scores (at rest and with ambulation) for CA-008 over the 72h inpatient stay [ Time Frame: At 72 hours ]
    10 point numerical rating scale (NRS) - Scale is 0 to 10. 0 no pain and 10 worse possible pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Healthy adult aged 18 - 65 years old
  2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
  3. Planning elective Bunionectomy repair
  4. For both males and females: using an acceptable method of birth control
  5. If a female: not pregnant or breastfeeding
  6. Have a body mass index ≤ 36 kg/m2

Exclusion Criteria:

  1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
  2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
  3. Have a known allergy to study medications.
  4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
  5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03885596

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United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
Concentric Analgesics
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Study Director: Mike Royal, M.D. Concentric Analgesics
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Responsible Party: Concentric Analgesics Identifier: NCT03885596    
Other Study ID Numbers: CA-PS-205
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No