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Total Knee ReplacementPhase 2NCT03541655

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

A Phase 2 study testing Bupivacaine HCl and F14 (celecoxib) in people with Total Knee Replacement and Postoperative Pain, run by Arthritis Innovation Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Total Knee Replacement, Postoperative Pain
What is being tested?
Bupivacaine HCl and F14 (celecoxib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
4 May 2018to 30 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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°
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  • 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

Who cannot join

  • 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
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  • 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
  • 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 clinically significant 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
  • 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
  • Unwilling or unable to discontinue use of NSAIDs within 7 days of scheduled surgery and for 3 months following study surgery, including low-dose aspirin for cardiac prophylaxis
  • Has an allergy or contraindication to opioids
  • Had a malignancy in the last year, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
  • Positive urine drug screen for disallowed medication at screening or preoperatively on day of study surgery

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Panorama Orthopedics & Spine Center

    Denver, Colorado, 80401

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Bupivacaine HCl, F14 (celecoxib)
Keywords
total knee replacement, pain, celecoxib, intra-articular
Medical subject headings
Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine HClDrug

    Also called Marcaine

    0.25% Bupivacaine HCl

  • F14 (celecoxib)Drug

    Celecoxib in novel drug delivery system (BEPO™)

Study groups in NCT03541655
Study groupRoleWhat they receive
Standard of care analgesiaActive comparator0.25% Bupivacaine HCl administered following total knee replacement
Receives: Drug: Bupivacaine HCl
F14 (celecoxib)Experimental3.5 mL dose of F14 (celecoxib) concurrent with 0.25% Bupivacaine HCl administered following total knee replacement
Receives: Drug: Bupivacaine HCl; Drug: F14 (celecoxib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak pain intensity measured by visual analog scale (VAS)

    Measured: At 2 weeks

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

    Measured: Through 72 hours

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

    Measured: Through 72 hours

  4. Functional improvement by Timed Up and Go test

    Measured: Through 3 months

  5. Total post-surgical opioid consumption (in MSO4 equivalents)

    Measured: Through 3 months

Secondary outcomes (6)

  1. Peak pain intensity by visual analog score (VAS)

    Measured: Through 12 months

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

    Measured: Through 12 months

  3. Time to first rescue medication

    Measured: Through 3 months

  4. Proportion of participants using rescue medication

    Measured: Through 3 months

  5. Benefit of analgesia by Overall Benefit of Analgesic Score (OBAS) questionnaire

    Measured: Through 4 weeks

  6. Celecoxib concentration in plasma

    Measured: Through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start4 May 2018
  3. Primary completion20 Jun 2019
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541655
Sponsor's protocol ID
100-CIP01-P
Status last verified
Jul 2020
First submitted
8 May 2018
Last updated
10 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bupivacaine HCl and F14 (celecoxib) in people with Total Knee Replacement and Postoperative Pain, run by Arthritis Innovation Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak pain intensity measured by visual analog scale (VAS) (time frame: At 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.

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