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Study of FX006 in Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT01487161
Recruitment Status : Completed
First Posted : December 7, 2011
Results First Posted : January 12, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis of the Knee
Interventions: Drug: FX006
Drug: TCA IR

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study took place at 22 centers across the United States, Canada and Australia. Enrollment took approximately 7 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened within 21 days of being randomized

Reporting Groups
  Description
FX006 10 mg 58 subjects received FX006 10 mg as a single 3 mL IA injection.
FX006 40 mg 59 subjects received FX006 40 mg as a single 3 mL IA injection.
FX006 60 mg 60 subjects received FX006 60 mg as a single 3 mL IA injection.
TCA IR (40 mg) 51 subjects received TCA IR 40 mg as a single 1 mL IA injection.

Participant Flow:   Overall Study
    FX006 10 mg   FX006 40 mg   FX006 60 mg   TCA IR (40 mg)
STARTED   58   59   60   52 
COMPLETED   56   57   59   50 
NOT COMPLETED   2   2   1   2 
Adverse Event                1                0                0                0 
Withdrawal by Subject                1                1                1                2 
missing data                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 229 patients were randomized to treatment in this study. 228 of 229 randomized patients received treatment and were included in the Safety Population; 1 patient randomized to the TCA IR group withdrew consent before receiving study treatment and was excluded.

Reporting Groups
  Description
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 mg) Single 1 mL IA injection
Total Total of all reporting groups

Baseline Measures
   FX006 10 mg   FX006 40 mg   FX006 60 mg   TCA IR (40 mg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   59   60   51   228 
Age 
[Units: Years]
Mean (Full Range)
 61.5 
 (43 to 82) 
 60.9 
 (40 to 80) 
 61.9 
 (44 to 86) 
 61.6 
 (42 to 83) 
 61.5 
 (40 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      26  44.8%      31  52.5%      34  56.7%      29  56.9%      120  52.6% 
Male      32  55.2%      28  47.5%      26  43.3%      22  43.1%      108  47.4% 


  Outcome Measures

1.  Primary:   Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg   [ Time Frame: 8 weeks ]

2.  Primary:   Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg   [ Time Frame: 10 weeks ]

3.  Primary:   Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg   [ Time Frame: 12 weeks ]

4.  Secondary:   Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg   [ Time Frame: Weeks 8, 10 and 12 ]

5.  Secondary:   Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.   [ Time Frame: Weeks 1-7 and Week 9 and 11 ]

6.  Secondary:   WOMAC A (Pain Subscale) Change From Baseline at Week 8   [ Time Frame: 8 weeks ]

7.  Secondary:   WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8   [ Time Frame: 8 weeks ]

8.  Secondary:   WOMAC B (Stiffness Subscale) Change From Baseline at Week 8   [ Time Frame: 8 weeks ]

9.  Secondary:   WOMAC C (Function Subscale) Change From Baseline at Week 8   [ Time Frame: 8 weeks ]

10.  Secondary:   Percent of Responders According to OMERACT-OARSI Criteria at Week 8   [ Time Frame: 8 weeks ]

11.  Secondary:   Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8   [ Time Frame: 8 weeks ]

12.  Secondary:   Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8   [ Time Frame: 8 weeks ]

13.  Secondary:   Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8   [ Time Frame: 8 weeks ]

14.  Secondary:   Patient Global Impression of Change Scores at Week 8   [ Time Frame: Week 8 ]

15.  Secondary:   Clinical Global Impression of Change Scores at Week 8   [ Time Frame: 8 weeks ]

16.  Secondary:   Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Kelley, VP of Medical Affairs
Organization: Flexion Therapeutics
phone: 781-305-7142
e-mail: skelley@flexiontherapeutics.com



Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01487161     History of Changes
Other Study ID Numbers: FX006-2011-001
First Submitted: December 5, 2011
First Posted: December 7, 2011
Results First Submitted: November 2, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 18, 2018