Safety and Activity of F14 for Management of Pain Following Total Knee Replacement

NCT03541655 | Completed Phase 2 FDA Drug

• 1 other identifier: 100-CIP01-P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The safety and activity of a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care analgesia administered following total knee replacement will be compared to standard of care analgesia alone.

Conditions

Total Knee Replacement; Postoperative Pain

Keywords

total knee replacement; pain; celecoxib; intra-articular

Outcome Measures

Primary Outcomes (5)

• Peak pain intensity measured by visual analog scale (VAS)

  At 2 weeks

• Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores

  Through 72 hours

• Summed pain intensity difference (SPID) of visual analog scale (VAS) pain intensity scores

  Through 72 hours

• Functional improvement by Timed Up and Go test

  Through 3 months

• Total post-surgical opioid consumption (in MSO4 equivalents)

  Through 3 months

Secondary Outcomes (6)

• Peak pain intensity by visual analog score (VAS)

  Through 12 months

• Pain, stiffness, and physical function by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Parts A, B, C)

  Through 12 months

• Time to first rescue medication

  Through 3 months

• Proportion of participants using rescue medication

  Through 3 months

• Benefit of analgesia by Overall Benefit of Analgesic Score (OBAS) questionnaire

  Through 4 weeks

Study Arms (2)

Standard of care analgesia

ACTIVE COMPARATOR

0.25% Bupivacaine HCl administered following total knee replacement

Drug: Bupivacaine HCl

F14 (celecoxib)

EXPERIMENTAL

3.5 mL dose of F14 (celecoxib) concurrent with 0.25% Bupivacaine HCl administered following total knee replacement

Drug: Bupivacaine HCl; Drug: F14 (celecoxib)

Interventions

Bupivacaine HCl DRUG

0.25% Bupivacaine HCl

Also known as: Marcaine

F14 (celecoxib); Standard of care analgesia

F14 (celecoxib) DRUG

Celecoxib in novel drug delivery system (BEPO™)

F14 (celecoxib)

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 female indicated for primary, unilateral 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 pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
• Absence of fixed flexion deformity exceeding 15°
• Absence of varus or valgus deformity exceeding 15°
• Minimum pre-operative flexion arc of 100°
• 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 pregnancy test at screening, who agree to employ adequate birth control measures for the full duration of the study
• Has undergone scheduled total knee replacement surgery of the index knee, which in the opinion of the Investigator, will not affect the participant's study follow-up

You may not qualify if:

• Allergy or hypersensitivity to active ingredient celecoxib. When an allergy to celecoxib is unknown,allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs
• Active or past infection in the index knee
• Previous total or partial knee arthroplasty in either knee within the past 6 months
• Prior arthroscopy in the index knee in the last 6 months; knee surgery other than arthroscopy (including cruciate ligament, cartilage or osteotomy) in the index knee in the last 12 months; knee surgery in the contralateral knee in the last 12 months (excluding total or partial knee replacement)
• Documented osteonecrosis or arthrotomy 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 scheduled surgery
• Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the TKR surgery emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) or back (by body diagram)
• Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate or affect the participant's study follow-up
• Strong narcotic use (e.g. Oxycontin®, Vicodin®, Percocet®) before scheduled study surgery for a prolonged period exceeding 30 days within the last 2 years
• History of alcohol abuse within previous 12 months (score of 4 on CAGE questionnaire)
• Known or suspected history of illicit drug abuse within 1 year before randomization, or history of opioid dependence within 2 years before scheduled surgery (score exceeding 5 on DAST-10 questionnaire)
• Participation in another clinical study involving an investigational product (IP) or device within 30 days before screening or scheduled participation in another clinical study involving an IP or device during the course of this study
• Use of pregabalin or gabapentin, or other drugs for neuropathic pain unless willing to discontinue at least 7 days prior to study surgery
• Current patient-reported seizure disorder

Sponsors & Collaborators

• Arthritis Innovation Corporation: lead

Study Sites (3)

Panorama Orthopedics & Spine Center

Denver, Colorado, 80401, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine; Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jared Foran, MD

  Panorama Orthopedics & Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 30, 2018
• Study Start: May 4, 2018
• Primary Completion: June 20, 2019
• Study Completion: March 30, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)