A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement

NCT05603832 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 100-CIP02-P
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase 3, randomized, double blind, multicenter study to evaluate the analgesic efficacy and safety of a single intra-articular dose of F14 (625 mg sustained release celecoxib) administered concurrent with multimodal analgesia in patients undergoing total knee replacement surgery, compared to multimodal analgesia alone.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Area Under the Curve (AUC) of numeric rating scale (NRS) pain scores

  2 weeks

Secondary Outcomes (5)

• Index knee range of motion (ROM) at 6 weeks

  6 weeks

• Time-weighted AUC of NRS pain scores

  7 Days

• Time-weighted AUC of NRS pain scores

  6 weeks

• Proportion of subjects using opioid rescue medication at 2 weeks

  2 weeks

• Time-weighted AUC of NRS pain scores

  3 days

Study Arms (2)

F14 + Multimodal Analgesia

EXPERIMENTAL

Drug: F14; Drug: 0.25 % Bupivacaine HCl; Drug: Acetaminophen; Drug: Methocarbamol

Multimodal Analgesia

ACTIVE COMPARATOR

Drug: 0.25 % Bupivacaine HCl; Drug: Acetaminophen; Drug: Methocarbamol

Interventions

F14 DRUG

625 mg intra-articular sustained-release celecoxib

F14 + Multimodal Analgesia

0.25 % Bupivacaine HCl DRUG

Local anesthetic

F14 + Multimodal Analgesia; Multimodal Analgesia

Acetaminophen DRUG

Analgesic

F14 + Multimodal Analgesia; Multimodal Analgesia

Methocarbamol DRUG

Muscle relaxant

F14 + Multimodal Analgesia; Multimodal Analgesia

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or females indicated for primary, unilateral total knee replacement (TKR)
• Between 45-80 years of age inclusive at the time of signing the informed consent
• Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol
• Body Mass Index (BMI) ≤ 40 kg/m2
• Medically stable as determined by the Investigator, based on physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings, as well as medical history from patient and pre-study source documents from other care providers
• Absence of moderate to severe fixed flexion deformity
• Absence of moderate to severe varus or valgus deformity
• Minimum pre-operative flexion arc of 100 degrees
• Absence of steroid, hyaluronic acid, platelet rich plasma, or any other type of therapeutic injection(s) in the index knee within 3 months before scheduled surgery
• American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3
• Females of childbearing potential with a negative serum pregnancy test at screening, or males that have a partner who is a woman of child-bearing potential (WOCBP), who agree to employ adequate birth control measures for the full duration of the study.

You may not qualify if:

• Known allergy or hypersensitivity to active ingredient celecoxib, OR known allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs when an allergy to celecoxib is unknown
• Unwilling or unable to discontinue use of nonsteroidal anti-inflammatory drugs (NSAIDs) at least 7 days before study surgery and for 6 weeks following study surgery
• Unwilling or unable to discontinue use of medical or recreational marijuana or cannabidiol (CBD) at least 10 days before study surgery and for 3 months following study surgery
• Unwilling or unable to discontinue use of pregabalin, gabapentin or other drugs for neuropathic pain at least 7 days prior to study surgery and for 3 months following study surgery
• Unwilling or unable to discontinue opioid analgesics at least 7 days prior to surgery
• Has an allergy or contraindication to opioids or NSAIDs or acetaminophen
• Active or past infection in the index knee
• Total or partial knee arthroplasty in the contralateral knee \< 6 months prior to study surgery
• Knee surgery (including cruciate ligament, cartilage or osteotomy) other than simple arthroscopy in either knee in the last 12 months (excluding contralateral total or partial knee replacement)
• Documented osteonecrosis within previous 12 months
• Prior or current presence of hardware in index knee other than screws from previous ligament repair that do not require manipulation or removal for TKR surgery
• Other planned major surgery within 12 months of study surgery
• Concurrent painful physical condition that is unrelated to the study knee (e.g., back, shoulder or contralateral knee pain) that will require analgesic treatment, such as NSAIDs or opioids, during study follow-up
• Current NRS pain intensity in the contralateral knee with a severity ≥ 4
• Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary or neurological, that, in the opinion of the Investigator, may increase the risk of surgery or complicate or affect the subject's study follow-up

Sponsors & Collaborators

• Allucent: collaborator
• Arthritis Innovation Corporation: lead

Study Sites (7)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Phoenix Clinical Research

Tamarac, Florida, 33321, United States

Location

The Orthopedic Center

Tulsa, Oklahoma, 74104, United States

Location

HD Research - First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

HD Research - Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

CenExel JBR

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

N-nitrosobis(2,2,3,3,4,4,4-heptafluorobutyl)amine; Bupivacaine; Acetaminophen; Methocarbamol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Matthew Shive, PhD

  Arthritis Innovation Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: November 17, 2022
• Primary Completion: November 22, 2023
• Study Completion: August 23, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (7)