Trial Outcomes & Findings for Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee (NCT NCT00790985)

Last Updated: 2022-11-01

Results Overview

WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome. For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen.

Recruitment status

COMPLETED

Study phase

Target enrollment

223 participants

Primary outcome timeframe

As measured at Baseline and Week 12

Results posted on

2022-11-01

Participant Flow

Subjects presented to their providers medical clinic At Screening anti-inflammatory meds discontinued. At Baseline inclusion, exclusion measured At Baseline randomization for eligible participants

Participant milestones

Participant milestones
Measure	Flavocoxid 500 mg flavonoid mixture flavocoxid: medical food	Naproxen 500 mg nonsteroidal anti-inflammatory drug Naproxen: antiinflammatory drug
Overall Study STARTED	108	115
Overall Study COMPLETED	106	114
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flavocoxid 500 mg n=108 Participants flavonoid mixture flavocoxid: medical food	Naproxen 500 mg n=115 Participants nonsteroidal anti-inflammatory drug Naproxen: antiinflammatory drug	Total n=223 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	0 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	0 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Age, Categorical Between 18 and 65 years	100 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	105 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	205 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Age, Categorical >=65 years	6 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	9 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	15 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Age, Continuous	60.64 years n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	61.08 years n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	60.86 years n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Sex: Female, Male Female	93 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	90 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	183 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Sex: Female, Male Male	13 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	24 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	37 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion
Region of Enrollment United States	106 Participants n=106 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	114 Participants n=114 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion	220 Participants n=220 Participants • 2 randomized to intervention discontinued prior to completion 1 randomized to placebo discontinued prior to completion

PRIMARY outcome

Timeframe: As measured at Baseline and Week 12

Outcome measures

Outcome measures
Measure	Naproxen n=106 Participants nonsteroidal anti-inflammatory drug Naproxen: antiinflammatory drug	Flavocoxid 500 mg n=114 Participants flavonoid mixture flavocoxid: medical food
Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.	85.75 percentage of change Standard Deviation 9.83	69.97 percentage of change Standard Deviation 7.34

Adverse Events

Flavocoxid 500 mg

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Naproxen 500 mg

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flavocoxid 500 mg n=108 participants at risk Intervention started at Baseline 500 mg BID (two times daily)	Naproxen 500 mg n=115 participants at risk Comparator started at Baseline 500 mg BID (two times daily)
Gastrointestinal disorders nausea dyspepsia	19.4% 21/108 • Number of events 21 • Screening to Week 12	33.9% 39/115 • Number of events 39 • Screening to Week 12
Vascular disorders edema	1.9% 2/108 • Number of events 2 • Screening to Week 12	8.7% 10/115 • Number of events 10 • Screening to Week 12

Additional Information

Robert Levy, MD., Director of Clinical Development

Primus Pharmaceuticals

Phone: 480-483-1410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60