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

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ClinicalTrials.gov Identifier: NCT03541655
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Arthritis Innovation Corporation

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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Postoperative Pain Drug: Bupivacaine HCl Drug: F14 (celecoxib) Phase 2

Detailed Description:
This is a randomized, single-blind, active control study in participants undergoing primary unilateral total knee replacement (TKR). Fifty (50) participants will be randomized 1:1 to receive either a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care analgesia, or only standard of care analgesia. F14 will be administered into the joint space at the end of surgery and just prior to wound closing. Safety will be evaluated through recording of adverse events, vital signs, ECG, physical and knee-specific examinations, laboratory blood tests and standing x-rays of the TKR obtained at 3 and 12 months. Post-operative pain will be assessed using visual analog scores (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires and the Timed Up and Go test. Concomitant medication usage including MSO4 equivalents will be monitored daily for 3 months with participant drug diaries, and at the 12-month visit. Perceived benefit of analgesia will be compared using the Overall Benefit of Analgesic Score (OBAS). The pharmacokinetic profile of celecoxib in plasma will be assessed up to 3 months. Standardized physical therapy will be implemented post-operatively. Follow-up study visits will occur at 1, 2, 3, 4 (phone) and 6 weeks, 3 and 12 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Single-Blind, Active-Control, Parallel Group Study to Evaluate Safety and Activity of a Single Administration of F14 for Management of Postoperative Pain in Participants Undergoing Unilateral Total Knee Replacement
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Standard of care analgesia
0.25% Bupivacaine HCl administered following total knee replacement
Drug: Bupivacaine HCl
0.25% Bupivacaine HCl
Other Name: Marcaine

Experimental: F14 (celecoxib)
3.5 mL dose of F14 (celecoxib) concurrent with 0.25% Bupivacaine HCl administered following total knee replacement
Drug: Bupivacaine HCl
0.25% Bupivacaine HCl
Other Name: Marcaine

Drug: F14 (celecoxib)
Celecoxib in novel drug delivery system (BEPO™)




Primary Outcome Measures :
  1. Peak pain intensity measured by visual analog scale (VAS) [ Time Frame: At 2 weeks ]
  2. Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores [ Time Frame: Through 72 hours ]
  3. Summed pain intensity difference (SPID) of visual analog scale (VAS) pain intensity scores [ Time Frame: Through 72 hours ]
  4. Functional improvement by Timed Up and Go test [ Time Frame: Through 3 months ]
  5. Total post-surgical opioid consumption (in MSO4 equivalents) [ Time Frame: Through 3 months ]

Secondary Outcome Measures :
  1. Peak pain intensity by visual analog score (VAS) [ Time Frame: Through 12 months ]
  2. Pain, stiffness, and physical function by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Parts A, B, C) [ Time Frame: Through 12 months ]
  3. Time to first rescue medication [ Time Frame: Through 3 months ]
  4. Proportion of participants using rescue medication [ Time Frame: Through 3 months ]
  5. Benefit of analgesia by Overall Benefit of Analgesic Score (OBAS) questionnaire [ Time Frame: Through 4 weeks ]
  6. Celecoxib concentration in plasma [ Time Frame: Through 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Allergy or hypersensitivity to active ingredient celecoxib, 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, or 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 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 Gabapentin or Lyrica, or other drugs for neuropathic pain unless willing to discontinue at least 7 days prior to study surgery
  • Current patient-reported seizure disorder
  • Current peripheral neuropathy
  • Current depression, mood or anxiety disorder (score exceeding 14 on PHQ-9 questionnaire)
  • History of complex regional pain syndrome (CRPS)
  • Diagnosis of liver and/or renal abnormalities within previous 2 years
  • Diagnosis of diabetes with HbA1c exceeding 7
  • Current inflammatory arthritides (e.g., rheumatoid arthritis, lupus erythematosus, ankylosing spondylitis, psoriatic arthritis), or traumatic bone injuries within 12 months before scheduled surgery, but excepting clinically stable/non-active gout that does not affect the knee and does not interfere with walking
  • Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of randomization, but excepting aspirin for cardiac prophylaxis (as long as discontinued within 7 days of scheduled surgery)
  • Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis
  • Participants with sleep apnea associated with a history of postoperative delirium. If symptomatic sleep apnea is currently treated with continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP), use must be continued postoperatively
  • History of coronary or vascular stent placed within 3 months (may be extended to 1 year if medically indicated per physician discretion).
  • Participation in active or pending personal injury or workers' compensation litigation related to index knee
  • Current or planned use of medical marijuana or cannabidiol (CBD), unless willing to discontinue at least 10 days prior to study surgery and for 3 months following study surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541655


Contacts
Contact: Matthew Shive, PhD 303-269-1213 matthewshive1@gmail.com

Locations
United States, Colorado
Panorama Orthopedics & Spine Center Recruiting
Denver, Colorado, United States, 80401
Contact: Raquel Phillips    720-497-6697    rephillips@panoramaortho.com   
Principal Investigator: Jared Foran, MD         
Sponsors and Collaborators
Arthritis Innovation Corporation
Investigators
Principal Investigator: Jared Foran, MD Panorama Orthopedics & Spine Center

Responsible Party: Arthritis Innovation Corporation
ClinicalTrials.gov Identifier: NCT03541655     History of Changes
Other Study ID Numbers: 100-CIP01-P
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arthritis Innovation Corporation:
total knee replacement
pain
celecoxib
intra-articular

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Celecoxib
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents