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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487200
• Other study ID #: FX006-2011-002
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• FX006 10 mg
single 3 mL IA injection
• FX006 40 mg
single 3 mL IA injection
• FX006 60 mg
single 3 mL IA injection
• TCA IR 40
single 1 mL IA injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Primary	Characterize the Pharmacokinetic Profile of FX006 and TCA IR	Concentrations below the limit of quantification of 50 pg/mL were treated as 0.	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	Change From Baseline in 24-hour Urinary Free Cortisol Excretion		Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
Secondary	Total 24-hour Urinary Free Cortisol Excretion		Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Secondary	Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol	Least square mean difference against TCA IR 40 mg	Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43