ClinicalTrials.Veeva

Menu

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

C

Cali Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Hallux Valgus and Bunion

Treatments

Drug: Analgesic Non Narcotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT05411861
CPL-01-202

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

73 participants in 3 patient groups, including a placebo group

CPL-01
Experimental group
Description:
Low dose of CPL-01
Treatment:
Drug: Analgesic Non Narcotic
Ropivacaine HCl
Active Comparator group
Description:
Low dose of Ropivacaine HCl
Treatment:
Drug: Analgesic Non Narcotic
Placebo
Placebo Comparator group
Description:
Low volume of placebo
Treatment:
Drug: Analgesic Non Narcotic

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems