Osteoarthritis of the KneePhase 2NCT01487200

Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

A Phase 2 study testing FX006 10 mg, FX006 40 mg and FX006 60 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 2 sites in Australia.

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 purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: FX006 10 mg, FX006 40 mg and FX006 60 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesAustralia
Study dates: Jul 2012to Nov 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=35 years of age
Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of the protocol-specified restricted medications

Main Exclusion Criteria:

History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament)
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of Screening
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
Insulin-dependent diabetes
History of or active Cushing's syndrome
Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
Skin breakdown at the knee where the injection would take place
Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Study site
Adelaide, South Australia, 5000
Study site
Perth, Western Australia

Other trials in Australia

About this study

Official title: A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee

The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Read the detailed description

This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

Conditions: Osteoarthritis of the Knee
Being tested: FX006 10 mg, FX006 40 mg, FX006 60 mg, TCA IR 40
Keywords: osteoarthritis, knee, corticosteroid, intra-articular, injection
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

FX006 10 mgDrug
single 3 mL IA injection
FX006 40 mgDrug
single 3 mL IA injection
FX006 60 mgDrug
single 3 mL IA injection
TCA IR 40Drug
Also called Kenalog®-40, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
single 1 mL IA injection

Study groups in NCT01487200
Study group	Role	What they receive
FX006 10mg	Experimental	Single 3 mL intra-articular (IA) injection Extended-release formulation Receives: Drug: FX006 10 mg
FX006 40mg	Experimental	Single 3 mL intra-articular (IA) injection Extended-release formulation Receives: Drug: FX006 40 mg
FX006 60 mg	Experimental	Single 3 mL intra-articular (IA) injection Extended-release formulation Receives: Drug: FX006 60 mg
TCA IR (40 mg)	Active comparator	Single 1 mL intra-articular (IA) injection Immediate-release formulation Receives: Drug: TCA IR 40

What is being measured

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

Change From Baseline in 24-hour Weighted Mean Serum Cortisol
The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24
Measured: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Characterize the Pharmacokinetic Profile of FX006 and TCA IR
Concentrations below the limit of quantification of 50 pg/mL were treated as 0.
Measured: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

Secondary outcomes (3)

Change From Baseline in 24-hour Urinary Free Cortisol Excretion
Measured: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
Total 24-hour Urinary Free Cortisol Excretion
Measured: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
Least square mean difference against TCA IR 40 mg
Measured: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

Timeline

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

Jul 2012Nov 2012

First posted7 Dec 2011 (estimated)
Study startJul 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01487200
Sponsor's protocol ID: FX006-2011-002
Status last verified: Jan 2024
First submitted: 5 Dec 2011
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT01487200
Acronym / sponsor ID: FX006-2011-002
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis, knee, corticosteroid, intra-articular, injection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 7 Dec 2011 (estimated)
Results: Posted 6 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Detailed description

This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
FX006 10mg	Experimental	Drug: FX006 10 mgSingle 3 mL intra-articular (IA) injection Extended-release formulation
FX006 40mg	Experimental	Drug: FX006 40 mgSingle 3 mL intra-articular (IA) injection Extended-release formulation
FX006 60 mg	Experimental	Drug: FX006 60 mgSingle 3 mL intra-articular (IA) injection Extended-release formulation
TCA IR (40 mg)	Active comparator	Drug: TCA IR 40Single 1 mL intra-articular (IA) injection Immediate-release formulation

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FX006 10 mgsingle 3 mL IA injection	Drug	FX006 10mg
FX006 40 mgsingle 3 mL IA injection	Drug	FX006 40mg
FX006 60 mgsingle 3 mL IA injection	Drug	FX006 60 mg
TCA IR 40Also: Kenalog®-40, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)single 1 mL IA injection	Drug	TCA IR (40 mg)

Primary outcome

Change From Baseline in 24-hour Weighted Mean Serum Cortisol
Time frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24
Characterize the Pharmacokinetic Profile of FX006 and TCA IR
Time frame: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43
Concentrations below the limit of quantification of 50 pg/mL were treated as 0.

3 secondary outcomes

Change From Baseline in 24-hour Urinary Free Cortisol Excretion
Time frame: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
Total 24-hour Urinary Free Cortisol Excretion
Time frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
Time frame: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

Results and safety

Results posted to the registry on 6 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FX006 10mg	5	5
FX006 40mg	7	6
FX006 60 mg	7	7
TCA IR 40 mg	5	5

Primary outcome: Change From Baseline in 24-hour Weighted Mean Serum Cortisol

Time frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6). Least squares mean (95% Confidence Interval). Unit: weighted mean serum cortisol (nmol/L)

Measure	FX006 10mg n = 5	FX006 40mg n = 7	FX006 60 mg n = 7	TCA IR 40 mg n = 5
Change from BL to Days 1 to 2	-7.7 (-38.4 to 38.3)	-42.7 (-59.2 to -19.4)	-62.2 (-73.2 to -46.8)	-59.0 (-72.6 to -38.6)
Change from BL to Days 14 to 15	-11.1 (-37.0 to 25.5)	-33.4 (-50.2 to -10.9)	-49.5 (-62.3 to -32.4)	-19.7 (-43.0 to 13.3)
Change in BL to Days 42 to 43	-9.0 (-26.2 to 12.3)	-18.0 (-32.2 to -0.7)	-11.8 (-26.1 to 5.4)	-4.8 (-22.7 to 17.4)

Primary outcome: Characterize the Pharmacokinetic Profile of FX006 and TCA IR

Time frame: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43. Geometric mean (Standard Deviation). Unit: pg/mL

Measure	FX006 10mg n = 5	FX006 40mg n = 7	FX006 60 mg n = 7	TCA IR 40 mg n = 5
1 hour postdose	140.941 (0.4767)	638.447 (0.6312)	862.574 (0.6823)	12268.835 (1.4681)
2 hours postdose	226.058 (0.2204)	779.819 (0.6778)	1164.013 (0.6772)	14243.604 (1.5643)
4 hours postdose	280.406 (0.3637)	860.476 (0.7088)	1251.776 (0.7030)	16282.659 (1.7765)
6 hours postdose	261.231 (0.4108)	814.647 (0.7131)	1182.925 (0.6952)	14560.886 (1.7754)
8 hours postdose	249.298 (0.4640)	748.962 (0.7898)	1227.658 (0.6245)	13543.427 (1.7347)
12 hours postdose	230.506 (0.5331)	691.962 (0.7456)	1127.476 (0.7841)	10112.863 (1.6684)
Day 2 (24 hrs post dose)	242.764 (0.4037)	763.568 (0.7423)	1309.260 (0.5869)	5421.894 (1.5196)
Day 3 (48 hrs post dose)	233.138 (0.3999)	743.344 (0.7583)	1294.042 (0.7645)	2371.778 (1.1844)

Population analysed: PK population was to include all patients who received study drug and had at least one measurable concentration

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from post injection on Day 1 through Day 43.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006 10mg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
FX006 40mg	0 of 7 (0%)	7 of 7 (100%)	0 of 7
FX006 60 mg	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
TCA IR 40 mg	0 of 5 (0%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neil Bodick, MD study director

Flexion Therapeutics

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FX006 10 mg, FX006 40 mg and FX006 60 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 2 sites in Australia.

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

Who may be eligible to take part?

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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. 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?

Yes. Results are posted in the registry (first posted 6 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in 24-hour Weighted Mean Serum Cortisol (time frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)). The study lists 2 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 NCT01487200.

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 24 Jan 2024.