Trial | NCT01291914  Report issue

Title

Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tafamidis ...

  • Study Participants

    140
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
The objectives of the study are to assess FX005, as compared to placebo control, for:

Safety and tolerability
Analgesic effect
Pharmacokinetics

Analgesic effect will be assessed using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.
Study Started
Dec 31
2010
Primary Completion
Jan 31
2012
Study Completion
Mar 31
2012
Last Update
Feb 28
2013
Estimate

Drug FX005

Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)

Drug Placebo 1 (Carrier)

Single intra-articular injection

Drug Placebo 2 (Diluent)

Single intra-articular injection

FX005 Experimental

Placebo 1 (Carrier) Placebo Comparator

Placebo 2 (Diluent) Placebo Comparator

Criteria 

Inclusion Criteria:

Male or female ≥40 years of age
Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
Kellgren-Lawrence grades II or III
Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
Body mass index ≤ 40 kg/m2
Willingness to abstain from use of restricted medications during the study
Willingness and ability to comply with the study procedures and visit schedule

Exclusion Criteria:

Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
Clinically apparent tense effusion in index knee
Presence of surgical hardware or other foreign body in the index knee
Clinical signs and symptoms of active knee infection or crystal disease
Intra-articular corticosteroid within 3 months of Screening
Intra-articular hyaluronic acid within 6 months of Screening
Other intra-articular therapy within 3 months 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 malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
Skin breakdown at the knee where the injection would take place
Women who are pregnant, nursing or likely to become pregnant during the time of the study
Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception
No Results Posted