Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

Hallux Valgus and Bunion Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411861
• Other study ID #: CPL-01-202
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: January 2023
• Source: Cali Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 7, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus
• Hallux Valgus and Bunion

Intervention

Drug:
• Analgesic Non Narcotic
Injection of protocol-specified volume of local analgesic

Locations

Country	Name	City	State
United States	Trovare Clinical Research	Bakersfield	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cali Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC72	Pain score through 72 hours post-operative	72 hours post-operative
Secondary	Opioid use (MME)	Opioid use through 72 hours post-operative	72 hours post-operative