Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

NCT05411861 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CPL-01-202
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Hallux Valgus and Bunion

Outcome Measures

Primary Outcomes (1)

• AUC72

  Pain score through 72 hours post-operative

  72 hours post-operative

Secondary Outcomes (1)

• Opioid use (MME)

  72 hours post-operative

Study Arms (3)

CPL-01

EXPERIMENTAL

Low dose of CPL-01

Drug: Analgesic Non Narcotic

Ropivacaine HCl

ACTIVE COMPARATOR

Low dose of Ropivacaine HCl

Drug: Analgesic Non Narcotic

Placebo

PLACEBO COMPARATOR

Low volume of placebo

Drug: Analgesic Non Narcotic

Interventions

Analgesic Non Narcotic DRUG

Injection of protocol-specified volume of local analgesic

Also known as: Infiltration of local analgesic

CPL-01; Placebo; Ropivacaine HCl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cali Pharmaceuticals LLC: lead

Study Sites (3)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Trovare Clinical Research

Bakersfield, California, 93301, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Interventions

Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Intervention Hierarchy (Ancestors)

Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Erol Onel

  Cali Biosciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Separate blinded and unblinded study teams
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Bunion Surgery

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: June 14, 2022
• Primary Completion: September 26, 2022
• Study Completion: November 7, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)