Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis (NCT NCT04182672)

NCT ID: NCT04182672

Last Updated: 2024-01-02

Results Overview

Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline,week 12
• Results posted on: 2024-01-02

Participant Flow

Unit of analysis: hips

Participant milestones

Measure	FX006 Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Overall Study STARTED	22 24
Overall Study COMPLETED	22 24
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

Baseline characteristics by cohort

Measure	FX006 n=22 Participants Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Age, Continuous	62.5 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Baseline Numeric Pain Rating Scale (NPRS) Score	5 score on a scale n=5 Participants
Baseline Patient Global Impression of Change (PGIC) score	2 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline,week 12

Population: Data were not collected for two participants in the FX006 arm.

Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

Outcome measures

Measure	FX006 n=20 Participants Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score	-2.25 score on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: from start of treatment to week 12 of treatment

Population: Data were not collected for two participants in the FX006 arm.

The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)

1. No change (or condition has got worse)

2. Almost the same, hardly any change at all

3. A little better, but no noticeable change

4. Somewhat better, but the change has not made any real difference

5. Moderately better, and a slight but noticeable change

6. Better, and a definite improvement that has made a real and worthwhile difference

7. A great deal better, and a considerable improvement that has made all the difference

Outcome measures

Measure	FX006 n=20 Participants Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Patient Global Impression of Change (PGIC) Score	5 score on a scale Interval 1.0 to 7.0

Adverse Events

FX006

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FX006 n=22 participants at risk Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
Musculoskeletal and connective tissue disorders Hip Pain	4.5% 1/22 • Number of events 1 • 12 weeks
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • 12 weeks
Nervous system disorders Fall	4.5% 1/22 • Number of events 1 • 12 weeks
Musculoskeletal and connective tissue disorders Pain at Injection Site	18.2% 4/22 • Number of events 4 • 12 weeks
Musculoskeletal and connective tissue disorders Subcutaneous and Skin Disorders-other-lump at injection site	4.5% 1/22 • Number of events 1 • 12 weeks

Additional Information

Pritish Bawa, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-7702

Email: Pritish.Bawa@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place