Trial Outcomes & Findings for Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee (NCT NCT02468583)

NCT ID: NCT02468583

Last Updated: 2024-01-24

Results Overview

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

5-10 Weeks

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	FX006 32 mg 3 subjects received FX006 32 mg as a single 5 mL IA injection	TCA IR 40 mg 3 subjects received TCA IR 40 mg as a single 1 mL IA injection
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FX006 32 mg n=3 Participants FX006: Single 5 mL IA injection	TCA IR 40 mg n=3 Participants TCA IR: Single 1 mL IA injection	Total n=6 Participants Total of all reporting groups
Age, Continuous	43 years n=5 Participants	40 years n=7 Participants	42 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5-10 Weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to >30% improvement

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing \>30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

FX006 32 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

TCA IR 40 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FX006 32 mg n=3 participants at risk FX006: Single 5 mL IA injection	TCA IR 40 mg n=3 participants at risk TCA IR: Single 3 mL IA injection
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.
Nervous system disorders Headache	66.7% 2/3 • Number of events 2 • Adverse Events were collected following IA administration through the final study visit at week 12.	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.
Injury, poisoning and procedural complications Contusion	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.
Infections and infestations Tooth Infection	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.
Infections and infestations Bronchitis	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.
Infections and infestations Blood triglycerides increased	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.
Investigations Blood cholesterol increased	0.00% 0/3 • Adverse Events were collected following IA administration through the final study visit at week 12.	33.3% 1/3 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at week 12.

Additional Information

Scott Kelley, VP of Medical Affairs

Flexion Therapeutics

Phone: 781-305-7142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place