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FX201 for Osteoarthritis

Phase 1
Waitlist Available
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually active females and males agree to use highly effective methods of contraception
Failed two or more types of conservative therapy for index knee osteoarthritis (e.g., structured exercise programs, topical or oral non-steroidal anti-inflammatory therapies); or failed one prior type of conservative therapy and at least one prior index knee IA treatment (corticosteroid or hyaluronic acid)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1, day 2, week 1, week 2, week 3, week 4
Awards & highlights

Study Summary

This trial will test a new drug, FX201, for treating painful osteoarthritis of the index knee. The trial will have a Single Ascending Dose (SAD) Phase, where a small number of patients will be given gradually increasing doses of the drug to test safety. The trial will also have an Expansion Phase, where a larger number of patients will be given the drug to further test safety and effectiveness.

Who is the study for?
This trial is for men and women aged 30-80 with painful knee osteoarthritis (K-L Grade 2, 3 or 4), a BMI ≤40 kg/m², who have tried at least two conservative therapies or one therapy plus an injection treatment without success. Participants must be willing to use effective contraception.Check my eligibility
What is being tested?
The study tests FX201, a new drug given as a single injection in the knee. The first part involves escalating doses in small groups monitored for safety. The second part expands patient numbers at each dose level after safety review.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort, and other risks typically associated with intra-articular injections which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use effective birth control methods if I'm sexually active.
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I have tried at least two treatments for my knee arthritis without success.
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I am between 30 and 80 years old.
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I experience moderate pain in one of my joints.
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I am between 30 and 80 years old.
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I experience moderate pain in one of my joints.
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I have tried at least two treatments for my knee arthritis without success.
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I have been diagnosed with knee osteoarthritis and have X-ray evidence.
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I have been diagnosed with knee osteoarthritis and have X-ray evidence.
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I use effective birth control methods if I'm sexually active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1, day 2, week 1, week 2, week 3, week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 2, week 1, week 2, week 3, week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure: Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201 (safety and tolerability)
Secondary outcome measures
Measure: Characterization of the systemic biodistribution of FX201 as seen through the percentage of patients positive for FX201 at Baseline, Day 1, Day 2, Week 1, Week 2, Week 3, and Week 4

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mid Dose FX201Experimental Treatment1 Intervention
Single mid dose FX201 injection
Group II: Low Dose FX201Experimental Treatment1 Intervention
Single low dose FX201 injection
Group III: High Dose FX201Experimental Treatment1 Intervention
Single high dose FX201 injection

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
133 Previous Clinical Trials
13,723 Total Patients Enrolled
21 Trials studying Osteoarthritis
4,510 Patients Enrolled for Osteoarthritis
Flexion Therapeutics, Inc.Lead Sponsor
19 Previous Clinical Trials
2,022 Total Patients Enrolled
16 Trials studying Osteoarthritis
1,880 Patients Enrolled for Osteoarthritis
Cecilia Barese, MDStudy DirectorPacira Pharmaceuticals, Inc

Media Library

FX201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04119687 — Phase 1
Osteoarthritis Research Study Groups: Low Dose FX201, Mid Dose FX201, High Dose FX201
Osteoarthritis Clinical Trial 2023: FX201 Highlights & Side Effects. Trial Name: NCT04119687 — Phase 1
FX201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04119687 — Phase 1
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04119687 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for people to partake in this experiment?

"According to clinicaltrials.gov, this trial is currently not recruiting participants, last updated on October 17th 2022 after its initial posting of November 30th 2019. Despite that there are 692 other trials open for recruitment at present."

Answered by AI

How many research sites have been included in this trial's oversight?

"This clinical trial is being conducted at the Center for Pharmaceutical Research located in Kansas City, Missouri; Arizona Research Centre based out of Phoenix, Arizona; and Metroplex Clinical Research Centre positioned in Dallas, Texas. There are also 8 additional sites where patients can participate."

Answered by AI

What risks have been documented with FX201 usage?

"The safety of FX201 is rated at 1, as the clinical trial for this drug intervention is still in its early stages. Consequently, there is limited evidence that it can produce desired outcomes safely."

Answered by AI

Is this trial restricted to people aged 65 and over?

"The lower limit of acceptance into this trial is 30 years old, while the upper threshold for eligibility caps at 80."

Answered by AI

Is there any possibility for me to join this experiment?

"This research study is searching for 72 individuals between 30 and 80 years old who have been clinically diagnosed with osteoarthritis of the knee, as confirmed by American College of Rheumatology criteria. Other requirements include a BMI under 40 kg/m2, moderate pain in their index joint, having failed two or more types of conservative therapy for OA in the past, and active contraception use if sexually active. Written consent to participate is also mandatory."

Answered by AI

Who else is applying?

What state do they live in?
Other
Texas
Pennsylvania
Arizona
How old are they?
18 - 65
65+
What site did they apply to?
Central Research Associates
Metroplex Clinical Research Center
Arizona Research Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I am an avid hiker, but pain in my right knee is starting to effect my mobility.
PatientReceived 1 prior treatment
I have tried PRP and HA injections and still suffer from OA despite being very active.
PatientReceived no prior treatments
I have tried pain relievers. I am told I am bone on bone on both knees left knee is the worst. I want to try anything before having to have surgery.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Arizona Research Center: < 48 hours
Average response time
  • < 2 Days
~14 spots leftby Mar 2025