Trial Outcomes & Findings for Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA) (NCT NCT00969501)

Results Overview

Greater than 50 percent reduction in pain scores from baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

6 months

Results posted on

2013-05-07

Participant milestones
Measure	EUFLEXXA All subjects received three injections (one each, in weeks 0 \[baseline\], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
Overall Study STARTED	32
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	5

Withdrawal data not reported

Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)

Baseline characteristics by cohort
Measure	EUFLEXXA n=32 Participants ACTIVE CONTROL
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	59.1 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

Timeframe: 6 months

Population:

Greater than 50 percent reduction in pain scores from baseline.

Outcome measures
Measure	EUFLEXXA n=27 Participants ACTIVE CONTROL
Number of Participants With a Reduction in Pain by the Scores.	25 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Georgia Institute for Clinical Research, LLC

Phone: 770-421-2030