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Trial record 6 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

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ClinicalTrials.gov Identifier: NCT03378076
Recruitment Status : Completed
First Posted : December 19, 2017
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bilateral Knee Osteoarthritis
Interventions Drug: FX006 32 mg
Drug: TAcs 40 mg
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FX006 32 mg TAcs IR 40 mg
Hide Arm/Group Description 12 subjects received FX006 32 mg as a single 5 mL IA injection into each knee for a total of total 64 mg dose 12 subjects received TAcs 40 mg as a single 5 mL IA injection into each knee for a total 80 mg dose
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title FX006 64 mg TAcs IR 80mg Total
Hide Arm/Group Description Single 5 mL IA injection into each knee Single 5 mL IA injection into each knee Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
61.8  (6.45) 61.6  (8.17) 61.7  (7.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
10
  83.3%
9
  75.0%
19
  79.2%
Male
2
  16.7%
3
  25.0%
5
  20.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
2
  16.7%
0
   0.0%
2
   8.3%
Not Hispanic or Latino
10
  83.3%
12
 100.0%
22
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
2
  16.7%
4
  16.7%
White
10
  83.3%
10
  83.3%
20
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 24 participants
33.31  (3.669) 30.35  (4.955) 31.83  (4.524)
1.Primary Outcome
Title Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Hide Description

Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.

For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations

Time Frame 43 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received 2 IA injections (one in each knee) of study drug, completed scheduled sampling, and had sufficient plasma concentration data
Arm/Group Title FX006 32 mg TAcs 40 mg
Hide Arm/Group Description:
Two 5 mL IA injections (total dose of 64 mg)
Two 1mL IA injections (total dose of 80 mg)
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Day 1- Hour 1
1801.5
(1261.50 to 2572.77)
4507.9
(1205.43 to 16857.74)
Day 1 - Hour 2
1893.6
(1328.58 to 2698.84)
5140.1
(1327.67 to 19899.79)
Day 1 - Hour 3
1958.1
(1336.54 to 2868.86)
5443.8
(1357.81 to 21825.90)
Day 1 - Hour 4
2013.8
(1381.39 to 2935.59)
5454.2
(1409.98 to 21098.36)
Day 1 - Hour 5
1914.4
(1291.93 to 2836.82)
5338.9
(1366.93 to 20852.59)
Day 1 - Hour 6
1900.2
(1293.77 to 2790.96)
5430.6
(1442.24 to 20448.57)
Day 1 - Hour 8
1928.1
(1288.45 to 2885.17)
5199.0
(1418.52 to 19054.80)
Day 1 - Hour 10
1839.8
(1241.72 to 2725.96)
4948.8
(1392.07 to 17593.31)
Day 1 - Hour 12
1793.9
(1247.06 to 2580.66)
4507.8
(1294.51 to 15697.14)
Day 2 - Hour 24
1948.8
(1349.93 to 2813.36)
4185.4
(1614.39 to 10850.75)
Day 8
1397.0
(1073.13 to 1818.65)
450.8
(230.66 to 880.92)
Day 15
956.2
(759.23 to 1204.25)
428.7
(231.92 to 792.29)
Day 29
445.8
(313.12 to 634.80)
334.6
(182.45 to 613.80)
Day 43
265.8
(199.56 to 354.03)
241.0
(119.11 to 487.54)
2.Primary Outcome
Title Incidence of Treatment Emergent Adverse Events
Hide Description

Safety analyses were conducted using the safety population.

Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).

Time Frame 43 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study drug (injection in at least one knee).
Arm/Group Title FX006 32 mg TAcs 40 mg
Hide Arm/Group Description:
Two 5 mL IA injections (total dose of 64 mg)
Two 1mL IA injections (total dose of 80 mg)
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
Patients with TEAE Grade 1 6 3
Patients with TEAE Grade 2 1 2
Patients with TEAE Grade 3 1 0
Patients with TEAE Grade 4 0 0
Patients with TEAE Grade 5 0 0
Time Frame Adverse Events were collected following IA administration through the final study visit at 6 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FX006 32 mg TAcs 40 mg
Hide Arm/Group Description

Two 5 mL intra-articular injection

FX006: Sustained Release Steroid

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

TAcs: Immediate Release Steroid

All-Cause Mortality
FX006 32 mg TAcs 40 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 32 mg TAcs 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FX006 32 mg TAcs 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      5/12 (41.67%)    
Gastrointestinal disorders     
Haemorrhoids  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Vomiting  1  1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
Fatigue  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Injection Site Pain  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Vessel Puncture Site Haematoma  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Immune system disorders     
Food Allergy  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Bronchitis  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Nasopharyngitis  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Sinusitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Investigations     
Neutrophil Count Decreased  1  1/12 (8.33%)  1 0/12 (0.00%)  0
White Blood Cell Count Decreased  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Back Pain  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Fibromyalgia  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Joint Swelling  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders     
Headache  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Pain  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Rhinorrhoea  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Vascular disorders     
Hot Flush  1  1/12 (8.33%)  1 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
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, Chief Medical Officer
Organization: Flexion Therapeutics
Phone: 781-305-7142
Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03378076     History of Changes
Other Study ID Numbers: FX006-2017-012
First Submitted: December 8, 2017
First Posted: December 19, 2017
Results First Submitted: March 4, 2019
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019