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Trial record 21 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT02003365
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: FX006 10 mg
Drug: FX006 40 mg
Drug: TCA IR 40 mg
Enrollment 50
Recruitment Details This study took place at 3 centers across the United States. Enrollment took approximately 2 months.
Pre-assignment Details Subjects were screened for eligibility within 14 days of being enrolled
Arm/Group Title FX006 10 mg FX006 40 mg TCA IR 40 mg
Hide Arm/Group Description 10 subjects received FX006 10 mg as a single 3 mL IA injection 30 Subjects received FX006 40 mg as a single 3 mL IA injection 10 subjects received TCA IR 40 mg as a single 1 mL IA injection
Period Title: Overall Study
Started 10 30 10
Completed 10 30 9
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Arm/Group Title FX006 10 mg FX006 40 mg TCA IR 40 mg Total
Hide Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection Total of all reporting groups
Overall Number of Baseline Participants 10 30 10 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 30 participants 10 participants 50 participants
61.5
(49 to 69)
62.8
(48 to 78)
61.6
(52 to 75)
62.15
(48 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 30 participants 10 participants 50 participants
Female
7
  70.0%
20
  66.7%
7
  70.0%
34
  68.0%
Male
3
  30.0%
10
  33.3%
3
  30.0%
16
  32.0%
1.Primary Outcome
Title Concentration of Triamcinolone Acetonide in Synovial Fluid
Hide Description

Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.

Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).

Time Frame 12 to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study drug and had synovial fluid obtained at the Final Visit were included in the Synovial Fluid Drug Concentration Population.
Arm/Group Title FX006 10 mg FX006 40 mg TCA IR 40 mg
Hide Arm/Group Description:
Single 3 mL IA injection.
Single 3 mL IA injection.
Single 1 mL IA injection.
Overall Number of Participants Analyzed 8 15 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Week 12
477.5
(166.41 to 1369.91)
923.7
(74.24 to 11492.46)
250.1
(0.16 to 380930.9)
Week 16
NA [1] 
(NA to NA)
224.3
(37.42 to 1344.70)
NA [2] 
(NA to NA)
Week 20
NA [1] 
(NA to NA)
33.3
(20.28 to 54.74)
NA [2] 
(NA to NA)
[1]
For the 10 mg group of FX006 patients were only followed until week 12.
[2]
TCA IR 40 mg group patients were only followed until week 12.
2.Secondary Outcome
Title Plasma Drug Concentrations by Time
Hide Description

Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.

Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).

Time Frame Weeks 6, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 10 mg FX006 40 mg TCA IR 40 mg
Hide Arm/Group Description:
Single 3 mL IA injection.
Single 3 mL IA injection.
Single 1 mL IA injection.
Overall Number of Participants Analyzed 10 30 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Week 6
26.5
(15.09 to 46.59)
100.1
(76.05 to 131.80)
21.1
(5.76 to 77.13)
Week 12
6.6
(4.26 to 10.26)
8.9
(3.97 to 19.79)
9.4
(1.86 to 47.40)
Week 16
NA [1] 
(NA to NA)
26.4
(8.75 to 79.64)
NA [2] 
(NA to NA)
Week 20
NA [1] 
(NA to NA)
10.1
(4.21 to 24.48)
NA [2] 
(NA to NA)
[1]
For the 10 mg group of FX006 patients were only followed until week 12.
[2]
For the TCA IR 40 mg group patients were only followed until week 12.
Time Frame Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FX006 10 mg FX006 40 mg TCA IR
Hide Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection
All-Cause Mortality
FX006 10 mg FX006 40 mg TCA IR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/30 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 10 mg FX006 40 mg TCA IR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/30 (0.00%)      2/10 (20.00%)    
Cardiac disorders       
Angina Pectoris * 1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications       
Food Poisoning * 1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA, version 16.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FX006 10 mg FX006 40 mg TCA IR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      5/30 (16.67%)      4/10 (40.00%)    
Cardiac disorders       
Angina pectoris  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders       
Abdominal Pain  1  1/10 (10.00%)  1 0/30 (0.00%)  0 0/10 (0.00%)  0
General disorders       
Tenderness  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations       
Upper Respiratory Tract Infection  1  2/10 (20.00%)  2 0/30 (0.00%)  0 0/10 (0.00%)  0
Viral Infection  1  1/10 (10.00%)  1 0/30 (0.00%)  0 0/10 (0.00%)  0
Nasopharyngitis  1  1/10 (10.00%)  1 0/30 (0.00%)  0 0/10 (0.00%)  0
Oral Herpes  1  1/10 (10.00%)  1 0/30 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications       
Food Poisoning  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Frostbite  1  1/10 (10.00%)  1 0/30 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/10 (0.00%)  0 3/30 (10.00%)  3 2/10 (20.00%)  2
Back Pain  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Muscle Spasms  1  0/10 (0.00%)  0 1/30 (3.33%)  1 1/10 (10.00%)  1
Musculoskeletal chest pain  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Neck Pain  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Pain in extremity  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Temporomandibular joint syndrome  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/10 (10.00%)  1 1/30 (3.33%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis contact  1  0/10 (0.00%)  0 0/30 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA, version 16.1
Indicates events were collected by systematic assessment
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
Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02003365     History of Changes
Other Study ID Numbers: FX006-2013-005
First Submitted: November 18, 2013
First Posted: December 6, 2013
Results First Submitted: October 24, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018