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Post-Operative Pain and Opioid Reduction Trial After Bunionectomy (MERIT-2)

Primary Purpose

Hallux Valgus and Bunion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Analgesic Non Narcotic
Sponsored by
Cali Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus and Bunion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be willing and able to sign the informed consent form (ICF) prior to study participation
  • In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization
  • Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
  • Have a BMI ≤ 39 kg/m2

Exclusion Criteria:

  • Previous unilateral simple bunionectomy
  • Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol
  • Concurrent painful condition
  • Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery
  • Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study
  • History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments
  • History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency
  • History or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis
  • History or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN)
  • History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix
  • Has or has had active COVID-19 infection within 3 months prior to surgery

Sites / Locations

  • Arizona Research Center
  • Trovare Clinical Research
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CPL-01

Ropivacaine HCl

Placebo

Arm Description

Low dose of CPL-01

Low dose of Ropivacaine HCl

Low volume of placebo

Outcomes

Primary Outcome Measures

AUC72
Pain score through 72 hours post-operative

Secondary Outcome Measures

Opioid use (MME)
Opioid use through 72 hours post-operative

Full Information

First Posted
June 7, 2022
Last Updated
January 9, 2023
Sponsor
Cali Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05411861
Brief Title
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
Acronym
MERIT-2
Official Title
Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cali Pharmaceuticals LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
Detailed Description
Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus and Bunion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Bunion Surgery
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Separate blinded and unblinded study teams
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPL-01
Arm Type
Experimental
Arm Description
Low dose of CPL-01
Arm Title
Ropivacaine HCl
Arm Type
Active Comparator
Arm Description
Low dose of Ropivacaine HCl
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Low volume of placebo
Intervention Type
Drug
Intervention Name(s)
Analgesic Non Narcotic
Other Intervention Name(s)
Infiltration of local analgesic
Intervention Description
Injection of protocol-specified volume of local analgesic
Primary Outcome Measure Information:
Title
AUC72
Description
Pain score through 72 hours post-operative
Time Frame
72 hours post-operative
Secondary Outcome Measure Information:
Title
Opioid use (MME)
Description
Opioid use through 72 hours post-operative
Time Frame
72 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be willing and able to sign the informed consent form (ICF) prior to study participation In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries Have a BMI ≤ 39 kg/m2 Exclusion Criteria: Previous unilateral simple bunionectomy Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol Concurrent painful condition Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency History or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis History or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN) History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix Has or has had active COVID-19 infection within 3 months prior to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erol Onel
Organizational Affiliation
Cali Biosciences
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Trovare Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

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