Trial Outcomes & Findings for Intra-articular Polyacrylamide Hydrogel in Gonarthrosis (NCT NCT06429319)
NCT ID: NCT06429319
Last Updated: 2025-02-06
Results Overview
Mean change in WOMAC-T from baseline (visit 0 \[screening\] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
COMPLETED
NA
65 participants
baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
2025-02-06
Participant Flow
Participant milestones
| Measure |
Group A
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 1/2 of the OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 3/4 of OLE.
|
Group C
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
43
|
17
|
|
Overall Study
COMPLETED
|
5
|
43
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
Baseline characteristics by cohort
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
71.60 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
63.53 years
STANDARD_DEVIATION 5.93 • n=7 Participants
|
61.88 years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
63.72 years
STANDARD_DEVIATION 7.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.28 kg/m^2
STANDARD_DEVIATION 2.32 • n=5 Participants
|
28.97 kg/m^2
STANDARD_DEVIATION 3.15 • n=7 Participants
|
27.18 kg/m^2
STANDARD_DEVIATION 1.82 • n=5 Participants
|
28.68 kg/m^2
STANDARD_DEVIATION 2.98 • n=4 Participants
|
|
Obesity
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study)
Mean change in WOMAC-T from baseline (visit 0 \[screening\] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Change in the Total WOMAC Score (WOMAC-T)
OLE visits 3
|
219.60 score on a scale
Standard Deviation 53.07
|
364.53 score on a scale
Standard Deviation 272.42
|
113.12 score on a scale
Standard Deviation 31.37
|
|
Change in the Total WOMAC Score (WOMAC-T)
OLE visits 5
|
179.20 score on a scale
Standard Deviation 64.87
|
262.16 score on a scale
Standard Deviation 216.67
|
78.94 score on a scale
Standard Deviation 20.77
|
|
Change in the Total WOMAC Score (WOMAC-T)
visit 1 study 1
|
649.80 score on a scale
Standard Deviation 509.54
|
1091.70 score on a scale
Standard Deviation 362.11
|
767.47 score on a scale
Standard Deviation 227.42
|
|
Change in the Total WOMAC Score (WOMAC-T)
OLE visit 0
|
293.60 score on a scale
Standard Deviation 243.62
|
376.00 score on a scale
Standard Deviation 274.06
|
260.29 score on a scale
Standard Deviation 150.02
|
SECONDARY outcome
Timeframe: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study).
Mean change in WOMAC-A from baseline (visit 1 (week 1) of the parent study AND visit 0 \[screening\] of OLE) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Change in the WOMAC Pain Score (WOMAC-A)
visit 1 study 1
|
125.80 score on a scale
Standard Deviation 99.55
|
211.02 score on a scale
Standard Deviation 77.97
|
158.18 score on a scale
Standard Deviation 63.77
|
|
Change in the WOMAC Pain Score (WOMAC-A)
OLE visit 0
|
60.00 score on a scale
Standard Deviation 51.53
|
67.26 score on a scale
Standard Deviation 52.72
|
44.24 score on a scale
Standard Deviation 28.77
|
|
Change in the WOMAC Pain Score (WOMAC-A)
OLE visit 3
|
38.00 score on a scale
Standard Deviation 18.33
|
65.02 score on a scale
Standard Deviation 51.23
|
6.29 score on a scale
Standard Deviation 3.89
|
|
Change in the WOMAC Pain Score (WOMAC-A)
OLE visit 5
|
30.00 score on a scale
Standard Deviation 25.67
|
47.98 score on a scale
Standard Deviation 44.80
|
3.12 score on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study).
Mean change in WOMAC-B from baseline (visit 0 \[screening\] of the OLE and visit 1 \[week 1\] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Change in the WOMAC Stiffness (WOMAC-B) Score
OLE visit 0
|
26.00 score on a scale
Standard Deviation 30.29
|
30.16 score on a scale
Standard Deviation 29.21
|
26.29 score on a scale
Standard Deviation 18.11
|
|
Change in the WOMAC Stiffness (WOMAC-B) Score
visit 1 study 1
|
78.60 score on a scale
Standard Deviation 69.50
|
95.23 score on a scale
Standard Deviation 43.13
|
69.94 score on a scale
Standard Deviation 26.93
|
|
Change in the WOMAC Stiffness (WOMAC-B) Score
OLE visit 3
|
15.80 score on a scale
Standard Deviation 6.83
|
28.05 score on a scale
Standard Deviation 29.85
|
21.24 score on a scale
Standard Deviation 6.71
|
|
Change in the WOMAC Stiffness (WOMAC-B) Score
OLE visit 5
|
12.20 score on a scale
Standard Deviation 7.60
|
20.63 score on a scale
Standard Deviation 25.03
|
12.12 score on a scale
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study)
Mean change in WOMAC-C from baseline (visit 0 \[screening\] of the OLE and visit 1 \[week 1\] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Change in the WOMAC Physical Function (WOMAC-C) Score
visit 1 study 1
|
445.40 score on a scale
Standard Deviation 364.01
|
785.44 score on a scale
Standard Deviation 280.73
|
539.35 score on a scale
Standard Deviation 170.29
|
|
Change in the WOMAC Physical Function (WOMAC-C) Score
OLE visit 0
|
207.60 score on a scale
Standard Deviation 165.18
|
278.58 score on a scale
Standard Deviation 200.64
|
189.76 score on a scale
Standard Deviation 109.22
|
|
Change in the WOMAC Physical Function (WOMAC-C) Score
OLE visit 3
|
165.80 score on a scale
Standard Deviation 32.77
|
271.47 score on a scale
Standard Deviation 200.43
|
85.59 score on a scale
Standard Deviation 24.11
|
|
Change in the WOMAC Physical Function (WOMAC-C) Score
OLE visit 5
|
137.00 score on a scale
Standard Deviation 37.14
|
193.56 score on a scale
Standard Deviation 154.29
|
63.71 score on a scale
Standard Deviation 16.15
|
SECONDARY outcome
Timeframe: baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study)
Mean change in the VAS pain score from baseline (visit 0 \[screening\] of the OLE and visit 1 \[week 1\] of the parent study to visit 2 (week 1), visit 3 (week 11) and visit 5 (week 23). The 0 to 100 mm visual analogue scale (VAS) was used for measuring pain intensity. VAS ratings between 0 and 4 mm were interpreted as no pain, 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. The pain VAS was self-completed by the patients.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
visit 5
|
6.20 score on a scale
Standard Deviation 5.59
|
16.56 score on a scale
Standard Deviation 12.32
|
4.88 score on a scale
Standard Deviation 3.14
|
|
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
study 1 visit 1
|
47.20 score on a scale
Standard Deviation 19.25
|
58.63 score on a scale
Standard Deviation 11.36
|
64.35 score on a scale
Standard Deviation 10.86
|
|
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
visit 0
|
30.80 score on a scale
Standard Deviation 16.33
|
17.33 score on a scale
Standard Deviation 10.18
|
9.47 score on a scale
Standard Deviation 5.51
|
|
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
visit 3
|
11.20 score on a scale
Standard Deviation 6.53
|
29.07 score on a scale
Standard Deviation 15.29
|
21.53 score on a scale
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: visits 3 (week 13) and 5 (week 25)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study)
Patient satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23).
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · without changes
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · evident aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · weak improvement
|
0 Participants
|
15 Participants
|
8 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · improvement
|
2 Participants
|
23 Participants
|
4 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 3 · significant improvement
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · evident aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · without changes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · weak improvement
|
0 Participants
|
12 Participants
|
1 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · improvement
|
1 Participants
|
25 Participants
|
16 Participants
|
|
Patient's Assessment of the Treatment Efficacy
Visit 5 · significant improvement
|
4 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: visits 3 (week 13) and 5 (week 25)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study).
Investigator satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23).
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · evident aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · without changes
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · weak improvement
|
1 Participants
|
14 Participants
|
8 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · improvement
|
2 Participants
|
23 Participants
|
4 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 3 · significant improvement
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · evident aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · aggravation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · without changes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · weak improvement
|
1 Participants
|
11 Participants
|
1 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · improvement
|
0 Participants
|
25 Participants
|
16 Participants
|
|
Investigator's Assessment of the Treatment Efficacy
Visit 5 · significant improvement
|
4 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: visits 3 (week 13) and 5 (week 25)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study). The mean number of tablets was calculated taking into account only patients who had received paracetamol.
A patient diary was used to capture data about the number of paracetamol 500 mg tablets taken.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Total Number of Paracetamol Tablets Taken
visit 3
|
0 paracetamol tablets
|
0 paracetamol tablets
|
0 paracetamol tablets
|
|
Total Number of Paracetamol Tablets Taken
visit 5
|
0 paracetamol tablets
|
0 paracetamol tablets
|
0 paracetamol tablets
|
SECONDARY outcome
Timeframe: visits 3 (week 11) and 5 (week 23)Population: The intent-to-treat (ITT) population (all subjects randomized in the parent study)
A patient diary was used to capture data about the number of NSAID tablets taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take protocol-permitted NSAID at certain doses.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
Total Number of NSAID Tablets Taken
visit 3
|
0 NSAID tablets
|
0 NSAID tablets
|
0 NSAID tablets
|
|
Total Number of NSAID Tablets Taken
visit 5
|
0 NSAID tablets
|
0 NSAID tablets
|
0 NSAID tablets
|
SECONDARY outcome
Timeframe: baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLEPopulation: The intent-to-treat (ITT) population (all subjects randomized in the parent study).
Joint space narrowing (JSN) was scored by comparison of subsequent radiographs taken over time. An increase in the radiographic knee JSN is associated with osteoarthritis progression.
Outcome measures
| Measure |
Group A
n=5 Participants
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 Participants
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 Participants
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study
|
|---|---|---|---|
|
The JSN in the Target Knee
|
-0.02 millimeters
Standard Deviation 0.05
|
-0.00 millimeters
Standard Deviation 0.19
|
0.02 millimeters
Standard Deviation 0.08
|
Adverse Events
Group A
Group B
Group C
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=5 participants at risk
Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 1/2 of the OLE (IA/PAAG-SI/OA/2020) study.
|
Group B
n=43 participants at risk
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 3/4 of OLE.
|
Group C
n=17 participants at risk
Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study.
|
|---|---|---|---|
|
Infections and infestations
Suspected coronavirus disease 2019 (COVID-19)
|
20.0%
1/5 • Number of events 1 • 6 months from visit 0 to visit 5.
Adverse events are counted in the safety population. The safety population completely overlapped with the ITT population.
|
0.00%
0/43 • 6 months from visit 0 to visit 5.
Adverse events are counted in the safety population. The safety population completely overlapped with the ITT population.
|
0.00%
0/17 • 6 months from visit 0 to visit 5.
Adverse events are counted in the safety population. The safety population completely overlapped with the ITT population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place