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
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: FX006
Drug: commercially available triamcinolone acetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Flexion Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FX006 10mg Drug: FX006
single intra-articular injection
Experimental: FX006 40mg Drug: FX006
single intra-articular injection
Experimental: FX006 60 mg Drug: FX006
single intra-articular injection
Active Comparator: commercially available triamcinolone acetonide (40 mg) Drug: commercially available triamcinolone acetonide
single intra-articular injection

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487200

Locations
Australia, South Australia
Adelaide, South Australia, Australia
Australia, Western Australia
Perth, Western Australia, Australia
Sponsors and Collaborators
Flexion Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01487200     History of Changes
Other Study ID Numbers: FX006-2011-002
Study First Received: December 5, 2011
Last Updated: November 16, 2012
Health Authority: Australia: Therapeutics Goods Administraion (TGA)

Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Knee
Steroid
intra-articular
injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014