Trial Outcomes & Findings for Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis (NCT NCT03897686)
NCT ID: NCT03897686
Last Updated: 2025-01-30
Results Overview
Mean change from baseline (week 1) to visit 5 (Week 25) in the total WOMAC score. Patients were asked to complete the questionnaire during the study visit 5. 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 health status and 2400 the worst possible status. The higher the score, the poorer the function.
COMPLETED
NA
144 participants
baseline (week 1), week 25
2025-01-30
Participant Flow
151 patients were selected for the study, of which 144 were randomised at 4 study sites from November 2019 to November 2020.
7 patients were classified as "screen failure" and 144 patients were randomized (1:1) to receive NOLTREX™ (n = 72) or placebo (n = 72).
Participant milestones
| Measure |
NOLTREX™, OA Grade II-III
72 patients with knee osteoarthritis grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits
|
Placebo, ОА Grade II-III
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
NOLTREX™, OA Grade II-III
72 patients with knee osteoarthritis grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits
|
Placebo, ОА Grade II-III
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly injections of the PAHG hydrous biopolymer with silver ions "Argiform" 4.0 ml (NOLTREX™) at the week 1 and 2 study visits.
|
Placebo, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
63.40 years
STANDARD_DEVIATION 7.26 • n=5 Participants
|
62.15 years
STANDARD_DEVIATION 7.54 • n=7 Participants
|
62.775 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasoid
|
72 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Mongoloid
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Negroid
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia · Clinical center 1
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Russia · Clinical center 2
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Russia · Clinical center 3
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Russia · Clinical center 4
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
BMI
|
28.75 kg/m^2
STANDARD_DEVIATION 2.97 • n=5 Participants
|
29.44 kg/m^2
STANDARD_DEVIATION 4.35 • n=7 Participants
|
29.095 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (week 1), week 25Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Mean change from baseline (week 1) to visit 5 (Week 25) in the total WOMAC score. Patients were asked to complete the questionnaire during the study visit 5. 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 health status and 2400 the worst possible status. The higher the score, the poorer the function.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Change of the Total WOMAC Score (WOMAC-T)
ОА grade II
|
-624.12 score on a scale
Interval -693.94 to -554.3
|
-444.82 score on a scale
Interval -517.41 to -372.22
|
|
Change of the Total WOMAC Score (WOMAC-T)
ОА grade II-III
|
-605.61 score on a scale
Interval -685.22 to -526.01
|
-426.31 score on a scale
Interval -501.66 to -350.96
|
|
Change of the Total WOMAC Score (WOMAC-T)
ОА grade III
|
-587.11 score on a scale
Interval -710.7 to -463.52
|
-407.81 score on a scale
Interval -524.27 to -291.35
|
SECONDARY outcome
Timeframe: baseline (week 1), week 13 (visit 4)Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Mean change from baseline (week 1) to Week 13 in the total WOMAC score. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 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 (0-96), where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Change of the Total WOMAC Score (WOMAC-T)
|
-532.57 score on a scale
Interval -609.74 to -455.4
|
-389.18 score on a scale
Interval -461.99 to -316.37
|
SECONDARY outcome
Timeframe: baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5)Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Pain score (WOMAC-A). 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. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
The Pain Subscale Score WOMAC-A Changes
Week 13
|
-110.94 score on a scale
Interval -127.4 to -94.48
|
-84.24 score on a scale
Interval -99.71 to -68.77
|
|
The Pain Subscale Score WOMAC-A Changes
Week 6
|
-68.55 score on a scale
Interval -84.26 to -52.84
|
-55.32 score on a scale
Interval -70.09 to -40.55
|
|
The Pain Subscale Score WOMAC-A Changes
Week 25
|
-130.95 score on a scale
Interval -147.88 to -114.03
|
-96.99 score on a scale
Interval -113.09 to -80.89
|
SECONDARY outcome
Timeframe: baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5)Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Stiffness (WOMAC-B) and WOMAC Physical Function (WOMAC-C) scores. Patients were asked to complete the questionnaire during the study visit 5. 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.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-C /Week 25
|
-436.92 score on a scale
Interval -494.86 to -378.97
|
-303.63 score on a scale
Interval -359.0 to -248.26
|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-C /Week 13
|
-374.17 score on a scale
Interval -430.0 to -318.34
|
-270.90 score on a scale
Interval -323.6 to -218.2
|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-B /Week 6
|
-27.25 score on a scale
Interval -35.68 to -18.81
|
-27.10 score on a scale
Interval -35.06 to -19.14
|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-B /Week 13
|
-48.46 score on a scale
Interval -57.16 to -39.74
|
-33.96 score on a scale
Interval -42.18 to -25.74
|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-B /Week 25
|
-54.79 score on a scale
Interval -62.48 to -47.1
|
-38.61 score on a scale
Interval -45.96 to -31.25
|
|
The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes
WOMAC-C /Week 6
|
-240.41 score on a scale
Interval -293.24 to -187.58
|
-183.26 score on a scale
Interval -233.13 to -133.39
|
SECONDARY outcome
Timeframe: Week 6, Week 13 and Week 25Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Patient satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25).
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Patient Assessment of Treatment Efficacy
Week 6, evident aggravation
|
0 participants
Interval 0.0 to 13.49
|
0 participants
Interval 0.0 to 13.33
|
|
Patient Assessment of Treatment Efficacy
Week 6,aggravation
|
0 participants
Interval 0.0 to 13.49
|
4 participants
Interval 1.23 to 21.73
|
|
Patient Assessment of Treatment Efficacy
Week 6, without changes
|
17 participants
Interval 11.4 to 43.52
|
21 participants
Interval 15.12 to 48.77
|
|
Patient Assessment of Treatment Efficacy
Week 6, weak improvement
|
18 participants
Interval 12.36 to 45.0
|
30 participants
Interval 24.75 to 60.81
|
|
Patient Assessment of Treatment Efficacy
Week 6, improvement
|
27 participants
Interval 21.74 to 57.55
|
13 participants
Interval 7.64 to 36.99
|
|
Patient Assessment of Treatment Efficacy
Week 6, significant improvement
|
9 participants
Interval 4.49 to 30.93
|
4 participants
Interval 1.23 to 21.73
|
|
Patient Assessment of Treatment Efficacy
Week 13,evident aggravation
|
0 participants
Interval 0.0 to 13.49
|
0 participants
Interval 0.0 to 13.33
|
|
Patient Assessment of Treatment Efficacy
Week 13,aggravation
|
0 participants
Interval 0.0 to 13.49
|
4 participants
Interval 1.23 to 21.73
|
|
Patient Assessment of Treatment Efficacy
Week 13, without changes
|
5 participants
Interval 1.8 to 23.88
|
17 participants
Interval 11.23 to 43.03
|
|
Patient Assessment of Treatment Efficacy
Week 13, weak improvement
|
18 participants
Interval 12.36 to 45.0
|
25 participants
Interval 19.26 to 54.26
|
|
Patient Assessment of Treatment Efficacy
Week 13, improvement
|
33 participants
Interval 28.63 to 65.28
|
19 participants
Interval 13.14 to 45.93
|
|
Patient Assessment of Treatment Efficacy
Week 13, significant improvement
|
15 participants
Interval 9.53 to 40.51
|
7 participants
Interval 3.02 to 27.16
|
|
Patient Assessment of Treatment Efficacy
Week 25,evident aggravation
|
0 participants
Interval 0.0 to 13.66
|
0 participants
Interval 0.0 to 13.66
|
|
Patient Assessment of Treatment Efficacy
Week 25, aggravation
|
0 participants
Interval 0.0 to 13.66
|
2 participants
Interval 0.39 to 18.2
|
|
Patient Assessment of Treatment Efficacy
Week 25, without changes
|
6 participants
Interval 2.44 to 26.02
|
19 participants
Interval 13.54 to 46.99
|
|
Patient Assessment of Treatment Efficacy
Week 25, weak improvement
|
14 participants
Interval 8.76 to 39.44
|
20 participants
Interval 14.55 to 48.45
|
|
Patient Assessment of Treatment Efficacy
Week 25, improvement
|
30 participants
Interval 25.52 to 62.15
|
20 participants
Interval 14.55 to 48.45
|
|
Patient Assessment of Treatment Efficacy
Week 25, significant improvement
|
20 participants
Interval 14.55 to 48.45
|
9 participants
Interval 4.56 to 31.3
|
SECONDARY outcome
Timeframe: Week 6, Week 13 and Week 25Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
Investigator satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25).
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Investigator Assessment of Treatment Efficacy
Week 6, evident aggravation
|
0 participants
Interval 0.0 to 13.49
|
0 participants
Interval 0.0 to 13.33
|
|
Investigator Assessment of Treatment Efficacy
Week 6,aggravation
|
0 participants
Interval 0.0 to 13.49
|
1 participants
Interval 0.11 to 15.63
|
|
Investigator Assessment of Treatment Efficacy
Week 6, without changes
|
17 participants
Interval 11.4 to 43.52
|
28 participants
Interval 22.51 to 58.23
|
|
Investigator Assessment of Treatment Efficacy
Week 6, weak improvement
|
18 participants
Interval 12.36 to 45.0
|
26 participants
Interval 20.33 to 55.59
|
|
Investigator Assessment of Treatment Efficacy
Week 6, improvement
|
28 participants
Interval 22.86 to 58.87
|
14 participants
Interval 8.51 to 38.53
|
|
Investigator Assessment of Treatment Efficacy
Week 6, significant improvement
|
8 participants
Interval 3.76 to 29.23
|
3 participants
Interval 0.76 to 19.79
|
|
Investigator Assessment of Treatment Efficacy
Week 13,evident aggravation
|
0 participants
Interval 0.0 to 13.49
|
0 participants
Interval 0.0 to 13.33
|
|
Investigator Assessment of Treatment Efficacy
Week 13,aggravation
|
0 participants
Interval 0.0 to 13.49
|
1 participants
Interval 0.11 to 15.63
|
|
Investigator Assessment of Treatment Efficacy
Week 13, without changes
|
7 participants
Interval 3.06 to 27.49
|
23 participants
Interval 17.16 to 51.54
|
|
Investigator Assessment of Treatment Efficacy
Week 13, weak improvement
|
18 participants
Interval 12.36 to 45.0
|
23 participants
Interval 17.16 to 51.54
|
|
Investigator Assessment of Treatment Efficacy
Week 13, improvement
|
35 participants
Interval 31.03 to 67.75
|
20 participants
Interval 14.12 to 47.36
|
|
Investigator Assessment of Treatment Efficacy
Week 13, significant improvement
|
11 participants
Interval 6.07 to 34.23
|
5 participants
Interval 1.77 to 23.59
|
|
Investigator Assessment of Treatment Efficacy
Week 25, evident aggravation
|
0 participants
Interval 0.0 to 13.33
|
1 participants
Interval 0.11 to 16.01
|
|
Investigator Assessment of Treatment Efficacy
Week 25, aggravation
|
1 participants
Interval 0.11 to 16.01
|
1 participants
Interval 0.11 to 16.01
|
|
Investigator Assessment of Treatment Efficacy
Week 25, without changes
|
7 participants
Interval 3.1 to 27.82
|
20 participants
Interval 14.55 to 48.45
|
|
Investigator Assessment of Treatment Efficacy
Week 25, weak improvement
|
13 participants
Interval 7.87 to 37.86
|
19 participants
Interval 13.54 to 46.99
|
|
Investigator Assessment of Treatment Efficacy
Week 25, improvement
|
31 participants
Interval 26.69 to 63.44
|
22 participants
Interval 16.62 to 51.31
|
|
Investigator Assessment of Treatment Efficacy
Week 25, significant improvement
|
18 participants
Interval 12.54 to 45.52
|
7 participants
Interval 3.1 to 27.82
|
SECONDARY outcome
Timeframe: week 6 (visit 3), week 13 (visit 4), week 25 (visit 5)Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
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 in certain doses.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Assessment of the Total Number of NSAID Tablets Taken
|
0 Number of NSAID tablets
|
0 Number of NSAID tablets
|
SECONDARY outcome
Timeframe: week 6 (visit 3), week 13 (visit 4), week 25 (visit 5)Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). 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 tablets taken.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Assessment of the Total Number of Paracetamol Tablets Taken
Week 6
|
3.08 mean number of paracetamol taken
Standard Deviation 3.75
|
6.00 mean number of paracetamol taken
Standard Deviation 5.63
|
|
Assessment of the Total Number of Paracetamol Tablets Taken
Week 13
|
1.75 mean number of paracetamol taken
Standard Deviation 1.39
|
8.47 mean number of paracetamol taken
Standard Deviation 6.67
|
|
Assessment of the Total Number of Paracetamol Tablets Taken
Week 25
|
1.00 mean number of paracetamol taken
Standard Deviation 0.00
|
11.79 mean number of paracetamol taken
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: Week 25Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
According to protocol the reasons for withdrawal included health status deterioration, investigator's decision, need in paracetamol use ≥4 days a week during 2 consecutive weeks, individual intolerance or contraindications to the study MD, placebo, paracetamol or any of the protocol-permitted NSAIDs; development of a AE/SAE requiring examination and/or treatment that can significantly affect the study procedures
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Patient Exclusion Rates Due to Safety
|
0 participants
Interval 0.0 to 4.99
|
0 participants
Interval 0.0 to 4.99
|
SECONDARY outcome
Timeframe: Week 25Population: The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention).
According to the protocol the reasons for patients drop-out included major protocol deviations (poor compliance) and withdrawal of informed consent.
Outcome measures
| Measure |
NOLTREX™, OA Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits.
|
Placebo, ОА Grade II-III
n=72 Participants
Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits.
|
|---|---|---|
|
Exclusion Rate Due to Poor Patient Compliance
|
1 participants
Interval 0.04 to 7.5
|
1 participants
Interval 0.04 to 7.5
|
Adverse Events
NOLTREX™, II-III Grade OA
Placebo, II-III Grade ОА
Serious adverse events
| Measure |
NOLTREX™, II-III Grade OA
n=72 participants at risk
patients with II-III grade of gonarthrosis will randomised to receive PAHG
hydrous biopolymer with silver ions "Argiform": 4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
In NOLTREX™ Group, 5 AEs occurred in 2 (2.78%) patients, and none of them was described as SAE.
|
Placebo, II-III Grade ОА
n=72 participants at risk
patients with II-III grade of gonarthrosis will randomised to receive saline solution
saline solution: 4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
In Placebo Group, 11 AEs occurred in 2 (2.78%) of patients, of them, in 1 (1.39%) patient SAE was registered.
|
|---|---|---|
|
Infections and infestations
community-acquired bilateral polysegmental pneumonia caused by coronavirus infection COVID-19
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Infections and infestations
Community-acquired bilateral polysegmental pneumonia caused by coronavirus infection COVID-19
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
Other adverse events
| Measure |
NOLTREX™, II-III Grade OA
n=72 participants at risk
patients with II-III grade of gonarthrosis will randomised to receive PAHG
hydrous biopolymer with silver ions "Argiform": 4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
In NOLTREX™ Group, 5 AEs occurred in 2 (2.78%) patients, and none of them was described as SAE.
|
Placebo, II-III Grade ОА
n=72 participants at risk
patients with II-III grade of gonarthrosis will randomised to receive saline solution
saline solution: 4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
In Placebo Group, 11 AEs occurred in 2 (2.78%) of patients, of them, in 1 (1.39%) patient SAE was registered.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine pain
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
4.2%
3/72 • Number of events 3 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Gastrointestinal disorders
Stomach ache
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
2.8%
2/72 • Number of events 2 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Nervous system disorders
Dizziness
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
General disorders
General weakness.
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Respiratory, thoracic and mediastinal disorders
A sore throat
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.00%
0/72 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
1.4%
1/72 • Number of events 1 • 1 year From 29-Nov-2019 to 17-Nov-2020
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER