Trial Outcomes & Findings for Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis (NCT NCT06523491)

Last Updated: 2025-09-17

Results Overview

Mean change in the total WOMAC score from visit 1 of the parent study (baseline), visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF) up to 24 months post Baseline Visit 1 Study 1. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status.

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)

Results posted on

2025-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	Group 2 NOLTREX™ Courses Group 2 NOLTREX™ courses consisted of 30 patients who had received 2 NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group 1 NOLTREX™ Course Group 1 NOLTREX™ course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE
Overall Study STARTED	30	17	10
Overall Study COMPLETED	30	17	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received one NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019; concomitant use of paracetamol (oral NSAIDs) was allowed) and had not taken part in OLE.	Total n=57 Participants Total of all reporting groups
Age, Continuous Age	63.73 Age in years STANDARD_DEVIATION 6.55 • n=93 Participants	61.71 Age in years STANDARD_DEVIATION 7.35 • n=4 Participants	64.30 Age in years STANDARD_DEVIATION 7.57 • n=27 Participants	63.23 Age in years STANDARD_DEVIATION 6.92 • n=483 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	10 Participants n=483 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	12 Participants n=4 Participants	8 Participants n=27 Participants	47 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	17 Participants n=4 Participants	10 Participants n=27 Participants	57 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Body weight	80.18 kilogram STANDARD_DEVIATION 11.87 • n=93 Participants	75.29 kilogram STANDARD_DEVIATION 5.61 • n=4 Participants	85.65 kilogram STANDARD_DEVIATION 12.05 • n=27 Participants	79.68 kilogram STANDARD_DEVIATION 10.85 • n=483 Participants
Body Mass Index (BMI)	29.06 kg/m^2 STANDARD_DEVIATION 3.26 • n=93 Participants	27.04 kg/m^2 STANDARD_DEVIATION 1.91 • n=4 Participants	30.25 kg/m^2 STANDARD_DEVIATION 3.09 • n=27 Participants	28.66 kg/m^2 STANDARD_DEVIATION 3.07 • n=483 Participants

PRIMARY outcome

Timeframe: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)

Population: Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group.

Outcome measures

Outcome measures
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE.
Change in the Total WOMAC Score (WOMAC-T) OLE visit 5	319.07 score on a scale Standard Deviation 203.24	78.94 score on a scale Standard Deviation 20.77	—
Change in the Total WOMAC Score (WOMAC-T) EOF	423.00 score on a scale Standard Deviation 250.02	50.82 score on a scale Standard Deviation 31.78	722.10 score on a scale Standard Deviation 246.71
Change in the Total WOMAC Score (WOMAC-T) visit 1 study 1	1137.13 score on a scale Standard Deviation 375.18	767.47 score on a scale Standard Deviation 227.42	1271.60 score on a scale Standard Deviation 247.29
Change in the Total WOMAC Score (WOMAC-T) OLE visit 0	445.33 score on a scale Standard Deviation 252.01	260.29 score on a scale Standard Deviation 150.02	616.00 score on a scale Standard Deviation 230.18

SECONDARY outcome

Mean change in WOMAC-A from baseline (visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain.

Outcome measures

Outcome measures
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE.
Change in the WOMAC Pain Score (WOMAC-A) visit 1 study 1	233.20 score on a scale Standard Deviation 77.68	158.18 score on a scale Standard Deviation 63.77	239.10 score on a scale Standard Deviation 68.76
Change in the WOMAC Pain Score (WOMAC-A) OLE visit 0	80.93 score on a scale Standard Deviation 50.74	44.24 score on a scale Standard Deviation 28.77	103.90 score on a scale Standard Deviation 48.31
Change in the WOMAC Pain Score (WOMAC-A) OLE visit 5	59.70 score on a scale Standard Deviation 43.68	3.12 score on a scale Standard Deviation 2.87	—
Change in the WOMAC Pain Score (WOMAC-A) EOF	80.27 score on a scale Standard Deviation 51.92	3.29 score on a scale Standard Deviation 3.74	131.10 score on a scale Standard Deviation 64.15

SECONDARY outcome

Mean change in WOMAC-B from baseline (visit 1 \[week 1\] of the parent study IA/PAAG-SI/OA/2019, visits 0 \[screening\] and 5 \[week 23\] of OLE IA/PAAG-SI/OA/2020) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness. Higher scores represent worse stiffness.

Outcome measures

Outcome measures
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE.
Change in the WOMAC Stiffness (WOMAC-B) Score visit 1 study 1	96.17 score on a scale Standard Deviation 38.32	69.94 score on a scale Standard Deviation 26.93	101.00 score on a scale Standard Deviation 24.51
Change in the WOMAC Stiffness (WOMAC-B) Score OLE visit 0	33.23 score on a scale Standard Deviation 26.38	26.29 score on a scale Standard Deviation 18.11	56.90 score on a scale Standard Deviation 32.63
Change in the WOMAC Stiffness (WOMAC-B) Score OLE visit 5	22.53 score on a scale Standard Deviation 20.70	21.24 score on a scale Standard Deviation 6.71	—
Change in the WOMAC Stiffness (WOMAC-B) Score EOF	31.63 score on a scale Standard Deviation 28.20	7.24 score on a scale Standard Deviation 5.58	62.20 score on a scale Standard Deviation 28.18

SECONDARY outcome

Mean change in WOMAC-C from the baseline visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-1700 for Physical Function. Higher scores represent worse functional limitations. The higher the score, the poorer the function.

Outcome measures

Outcome measures
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE.
Change in the WOMAC Physical Function (WOMAC-C) Score visit 1 study 1	807.77 score on a scale Standard Deviation 295.02	539.35 score on a scale Standard Deviation 170.29	931.50 score on a scale Standard Deviation 182.82
Change in the WOMAC Physical Function (WOMAC-C) Score OLE visit 0	331.17 score on a scale Standard Deviation 186.01	189.76 score on a scale Standard Deviation 109.22	455.20 score on a scale Standard Deviation 158.93
Change in the WOMAC Physical Function (WOMAC-C) Score OLE visit 5	236.83 score on a scale Standard Deviation 146.82	85.59 score on a scale Standard Deviation 24.11	—
Change in the WOMAC Physical Function (WOMAC-C) Score EOF	311.10 score on a scale Standard Deviation 175.33	40.29 score on a scale Standard Deviation 23.94	528.80 score on a scale Standard Deviation 168.15

SECONDARY outcome

Mean change in the VAS pain score from the baseline visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF). The visual analog scale (VAS) is one of the most commonly used measures of pain intensity. The pain VAS was self-completed by the respondent. The respondent was asked to place the slider perpendicular to the VAS line at the point that represents their pain intensity. The score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Outcome measures

Outcome measures
Measure	Group NOLTREX™ 2 Courses n=30 Participants Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020).	Group NOLTREX™ 1 Course n=17 Participants Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).	Placebo Group n=10 Participants Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE.
Change in the 100-mm VAS Pain Score OLE visit 0	20.90 score on a scale Standard Deviation 9.82	9.47 score on a scale Standard Deviation 5.51	—
Change in the 100-mm VAS Pain Score visit 1 study 1	61.23 score on a scale Standard Deviation 10.90	64.35 score on a scale Standard Deviation 10.86	59.50 score on a scale Standard Deviation 10.09
Change in the 100-mm VAS Pain Score OLE visit 5	20.80 score on a scale Standard Deviation 12.00	4.88 score on a scale Standard Deviation 3.14	—
Change in the 100-mm VAS Pain Score EOF	28.43 score on a scale Standard Deviation 12.46	9.88 score on a scale Standard Deviation 13.41	42.70 score on a scale Standard Deviation 13.53

Adverse Events

Group NOLTREX™ 2 Courses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group NOLTREX™ 1 Course

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Melentyeva Commercial Director

RCBIOFORM

Phone: 84952237095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place