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Trial record 19 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

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ClinicalTrials.gov Identifier: NCT02637323
Recruitment Status : Completed
First Posted : December 22, 2015
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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: FX006 32 mg
Drug: TCA IR 40
Enrollment 81
Recruitment Details Patients were screened for study eligibility at four (4) study centers in the United States (US).
Pre-assignment Details Patients were enrolled sequentially with at least 10 patients per Cohort. Subjects were enrolled within 14 days of Screening.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description 63 subjects received FX006 32 mg as a single 5 mL IA injection 18 subjects received TCA IR 40 mg as a single 1 mL IA injection
Period Title: Overall Study
Started 63 18
Completed 61 17
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             0
Protocol Violation             0             1
Arm/Group Title FX006 32 mg TCA IR 40 mg Total
Hide Arm/Group Description Single 5 mL IA injection Single 1 mL IA injection Total of all reporting groups
Overall Number of Baseline Participants 63 18 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 18 participants 81 participants
59.9  (8.16) 61.9  (7.68) 61  (8.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 18 participants 81 participants
Female
32
  50.8%
13
  72.2%
45
  55.6%
Male
31
  49.2%
5
  27.8%
36
  44.4%
1.Primary Outcome
Title Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Hide Description All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
Time Frame Up to 20 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study drug and had synovial fluid obtained at the Synovial Fluid Visit and assayed for drug concentration levels.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
Single 5 mL IA injection
Single 1 mL IA injection
Overall Number of Participants Analyzed 17 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Baseline (pre-treatment) Number Analyzed 17 participants 5 participants
1.0
(1.00 to 1.00)
1.0
(1.00 to 1.00)
Week 1 Number Analyzed 8 participants 0 participants
231328.9
(56460.40 to 947798.36)
Week 6 Number Analyzed 6 participants 8 participants
3590.0
(32.89 to 391914.74)
7.7
(0.31 to 191.34)
Week 12 Number Analyzed 9 participants 0 participants
290.6
(15.67 to 5390.53)
Week 16 Number Analyzed 2 participants 0 participants
1.0
(1.00 to 1.00)
Week 20 Number Analyzed 4 participants 0 participants
1.0
(1.00 to 1.00)
2.Secondary Outcome
Title Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Hide Description All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.
Time Frame Up to 20 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study drug and had at least one post-baseline plasma sample obtained and assayed for drug concentration levels.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
Single 5mL IA injection
Single 1 mL IA injection
Overall Number of Participants Analyzed 60 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Day 1 - Hour 1 Number Analyzed 60 participants 18 participants
670.0
(558.42 to 803.97)
6968.8
(3329.00 to 14588.36)
Day 1 - Hour 2 Number Analyzed 60 participants 18 participants
736.5
(630.01 to 861.03)
8494.7
(3954.18 to 18248.99)
Day 1 - Hour 4 Number Analyzed 60 participants 18 participants
759.5
(641.69 to 898.87)
9628.8
(4420.47 to 20973.81)
Day 1 - Hour 6 Number Analyzed 60 participants 18 participants
747.1
(630.45 to 885.28)
9314.3
(4423.76 to 19611.37)
Day 1 - Hour 8 Number Analyzed 60 participants 18 participants
740.2
(625.13 to 876.36)
8421.3
(4166.33 to 17021.86)
Day 1 - Hour 10 Number Analyzed 60 participants 18 participants
720.7
(611.37 to 849.66)
7439.3
(3845.19 to 14392.79)
Day 1 - Hour 12 Number Analyzed 60 participants 18 participants
706.6
(600.15 to 831.91)
6678.7
(3535.07 to 12617.78)
Day 2 - Hour 24 Number Analyzed 60 participants 18 participants
836.4
(703.47 to 994.33)
4991.1
(2851.47 to 8736.28)
Week 1 Number Analyzed 11 participants 0 participants
600.9
(382.79 to 943.25)
Week 6 Number Analyzed 54 participants 17 participants
118.6
(99.93 to 140.87)
149.4
(69.70 to 320.32)
Week 12 Number Analyzed 15 participants 0 participants
53.7
(30.46 to 94.74)
Week 16 Number Analyzed 15 participants 0 participants
73.8
(28.74 to 189.31)
Week 20 Number Analyzed 8 participants 0 participants
108.2
(2.30 to 5090.25)
3.Other Pre-specified Outcome
Title Plasma Pharmacokinetic Parameters for FX006 and TCA IR
Hide Description [Not Specified]
Time Frame Up to 20 Weeks
Outcome Measure Data Not Reported
Time Frame Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description

Single 5 mL intra-articular injection

FX006: Sustained Release Steroid

Commercially available triamcinolone acetonide, single 1 mL intra-articular injection

TCA IR: Immediate Release Steroid

All-Cause Mortality
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)      0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/63 (1.59%)      0/18 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  1  1/63 (1.59%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/63 (11.11%)      2/18 (11.11%)    
Infections and infestations     
Nasopharyngitis  1  1/63 (1.59%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications     
Foot Fracture  1  1/63 (1.59%)  1 0/18 (0.00%) 
Investigations     
Weight Increased  1  1/63 (1.59%)  1 0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/63 (1.59%)  1 0/18 (0.00%) 
Patellofemoral Pain Syndrome  1  1/63 (1.59%)  1 0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  1  1/63 (1.59%)  1 0/18 (0.00%) 
Vascular disorders     
Hypertension  1  2/63 (3.17%)  2 0/18 (0.00%) 
Flushing  1  0/63 (0.00%)  2/18 (11.11%)  2
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.
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: NCT02637323     History of Changes
Other Study ID Numbers: FX006-2015-009
First Submitted: December 7, 2015
First Posted: December 22, 2015
Results First Submitted: October 24, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018