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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01487200
First received: December 5, 2011
Last updated: November 16, 2012
Last verified: November 2012

December 5, 2011
November 16, 2012
July 2012
November 2012   (final data collection date for primary outcome measure)
  • Change from baseline in 24-hour weighted mean serum cortisol [ Time Frame: at Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: through 6 weeks ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetic profile [ Time Frame: Day 1 (pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487200 on ClinicalTrials.gov Archive Site
  • Change from baseline in 24-hour urinary free cortisol excretion [ Time Frame: at Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) ] [ Designated as safety issue: No ]
  • Total 24-hour urinary free cortisol excretion [ Time Frame: at Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) ] [ Designated as safety issue: No ]
  • Change from baseline to each measured time point post-dose in morning serum cortisol [ Time Frame: through Week 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
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 is to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

This study will be a double-blind, randomized, parallel-group, active comparator design.

Twenty-four patients with knee osteoarthritis (OA) will be randomized to be treated with a single IA injection of 10, 40, or 60 mg of FX006 or 40 mg of commercially available triamcinolone acetonide.

Each patient will be evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics will be 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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: FX006
    single intra-articular injection
  • Drug: commercially available triamcinolone acetonide
    single intra-articular injection
  • Experimental: FX006 10mg
    Intervention: Drug: FX006
  • Experimental: FX006 40mg
    Intervention: Drug: FX006
  • Experimental: FX006 60 mg
    Intervention: Drug: FX006
  • Active Comparator: commercially available triamcinolone acetonide (40 mg)
    Intervention: Drug: commercially available triamcinolone acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01487200
FX006-2011-002
No
Flexion Therapeutics, Inc.
Flexion Therapeutics, Inc.
Not Provided
Not Provided
Flexion Therapeutics, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP