Trial Outcomes & Findings for Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI (NCT NCT01354145)
NCT ID: NCT01354145
Last Updated: 2016-08-19
Results Overview
To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.
COMPLETED
PHASE3
194 participants
12 months (Day 364) and 24 months (Day 728)
2016-08-19
Participant Flow
Participant milestones
| Measure |
Chondroitin Sulfate (Condrosan)
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
97
|
|
Overall Study
COMPLETED
|
58
|
63
|
|
Overall Study
NOT COMPLETED
|
39
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI
Baseline characteristics by cohort
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Cartilage Volume in the Lateral Compartment
|
6606 cubic milimeters
STANDARD_DEVIATION 2332 • n=5 Participants
|
6343 cubic milimeters
STANDARD_DEVIATION 1565 • n=7 Participants
|
6475 cubic milimeters
STANDARD_DEVIATION 1985 • n=5 Participants
|
|
Cartilage Volume in the Medial Compartment
|
6059 cubic milimeters
STANDARD_DEVIATION 2031 • n=5 Participants
|
5705 cubic milimeters
STANDARD_DEVIATION 1572 • n=7 Participants
|
5882 cubic milimeters
STANDARD_DEVIATION 1820 • n=5 Participants
|
|
Cartilage Volume in the Global Knee
|
12665 cubic milimeters
STANDARD_DEVIATION 4259 • n=5 Participants
|
12048 cubic milimeters
STANDARD_DEVIATION 2969 • n=7 Participants
|
12356 cubic milimeters
STANDARD_DEVIATION 3674 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Cartilage Volume Loss of the Lateral Compartment
Visit 6 (Day 364)
|
6408 cubic milimeters
Standard Deviation 97
|
6196 cubic milimeters
Standard Deviation 97
|
|
Cartilage Volume Loss of the Lateral Compartment
Visit 9 (Day 728)
|
6196 cubic milimeters
Standard Deviation 99
|
6143 cubic milimeters
Standard Deviation 99
|
SECONDARY outcome
Timeframe: 12 months (Day 364) and 24 months (Day 728)Population: Intention-to-Treat
To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Cartilage Volume Loss of the Global Knee
Visit 6 (Day 364)
|
12210 cubic milimeters
Standard Deviation 175
|
11770 cubic milimeters
Standard Deviation 175
|
|
Cartilage Volume Loss of the Global Knee
Visit 9 (Day 728)
|
11877 cubic milimeters
Standard Deviation 179
|
11572 cubic milimeters
Standard Deviation 179
|
SECONDARY outcome
Timeframe: 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Cartilage Volume in the Medial Compartment
Visit 6 (Day 364)
|
5793 cubic milimeters
Standard Deviation 83
|
5586 cubic milimeters
Standard Deviation 84
|
|
Cartilage Volume in the Medial Compartment
Visit 9 (Day 728)
|
5672 cubic milimeters
Standard Deviation 87
|
5439 cubic milimeters
Standard Deviation 87
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Synovial Membrane Thickness
Visit 9 (Day 728)
|
1.19 milimeters
Standard Deviation 0.26
|
1.16 milimeters
Standard Deviation 0.31
|
|
Synovial Membrane Thickness
Visit 2 (Baseline)
|
0.99 milimeters
Standard Deviation 0.22
|
0.96 milimeters
Standard Deviation 0.22
|
|
Synovial Membrane Thickness
Visit 6 (Day 364)
|
1.05 milimeters
Standard Deviation 0.22
|
1.07 milimeters
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows: * Grade 0 = Absence of lesion in the sub region * Grade 1 = less than 25% of the surface * Grade 2 = 25-50% of the surface * Grade 3 = more than 50% of the surface
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Bone Marrow Lesions Score
Global Knee - Visit 2 (Baseline)
|
2.57 units on a scale
Standard Deviation 3.04
|
2.65 units on a scale
Standard Deviation 2.51
|
|
Bone Marrow Lesions Score
Global Knee - Visit 6 (Day 364)
|
3.16 units on a scale
Standard Deviation 3.53
|
2.77 units on a scale
Standard Deviation 2.40
|
|
Bone Marrow Lesions Score
Global Knee - Visit 9 (Day 728)
|
3.58 units on a scale
Standard Deviation 3.68
|
3.37 units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Synovial Fluid Volume
Visit 2 (Baseline)
|
13.83 mililiters
Standard Deviation 14.61
|
10.79 mililiters
Standard Deviation 10.94
|
|
Synovial Fluid Volume
Visit 6 (Day 364)
|
10.30 mililiters
Standard Deviation 10.08
|
9.49 mililiters
Standard Deviation 12.06
|
|
Synovial Fluid Volume
Visit 9 (Day 728)
|
10.97 mililiters
Standard Deviation 14.52
|
9.07 mililiters
Standard Deviation 13.60
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 2 (Baseline) Medial meniscus
|
47.4 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 6 (Day 364) Medial meniscus
|
53.6 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 9 (Day 728) Medial meniscus
|
56.1 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 2 (Baseline) Lateral meniscus
|
6.2 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 6 (Day 364) Lateral meniscus
|
7.2 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With the Presence of Extrusion in the Meniscus
Visit 9 (Day 728) Lateral meniscus
|
8.8 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable".
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Visual Analog Scale (VAS)
Visit 2 (Baseline)
|
6.24 centimeters
Standard Deviation 1.55
|
5.93 centimeters
Standard Deviation 1.81
|
|
Visual Analog Scale (VAS)
Visit 6 (Day 364)
|
3.43 centimeters
Standard Deviation 2.60
|
3.02 centimeters
Standard Deviation 2.51
|
|
Visual Analog Scale (VAS)
Visit 9 (Day 728)
|
3.12 centimeters
Standard Deviation 2.85
|
2.45 centimeters
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
WOMAC Pain Subscale
Visit 2 (Baseline)
|
25.6 centimeters
Standard Deviation 8.11
|
25.51 centimeters
Standard Deviation 9.04
|
|
WOMAC Pain Subscale
Visit 6 (Day 364)
|
14.71 centimeters
Standard Deviation 11.55
|
13.62 centimeters
Standard Deviation 11.49
|
|
WOMAC Pain Subscale
Visit 9 (Day 728)
|
13.51 centimeters
Standard Deviation 12.67
|
10.69 centimeters
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
Western Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
WOMAC Stiffness Subscale
Visit 2 (Baseline)
|
10.76 centimeters
Standard Deviation 3.68
|
11.65 centimeters
Standard Deviation 4.25
|
|
WOMAC Stiffness Subscale
Visit 6 (Day 364)
|
6.53 centimeters
Standard Deviation 4.76
|
6.60 centimeters
Standard Deviation 5.31
|
|
WOMAC Stiffness Subscale
Visit 9 (Day 728)
|
6.15 centimeters
Standard Deviation 5.27
|
5.44 centimeters
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
Western Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
WOMAC Function Subscale
Visit 6 (Day 364)
|
52.3 centimeters
Standard Deviation 39.1
|
51.0 centimeters
Standard Deviation 42.7
|
|
WOMAC Function Subscale
Visit 2 (Baseline)
|
88.5 centimeters
Standard Deviation 28.7
|
89.5 centimeters
Standard Deviation 32.5
|
|
WOMAC Function Subscale
Visit 9 (Day 728)
|
50.0 centimeters
Standard Deviation 44.4
|
46.2 centimeters
Standard Deviation 41.4
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
The SF-36 is composed of 35 items measuring: * 8 health concepts (or dimensions), \[(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)\] * and 1 reported health transition item. The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Short Form (SF-36) Health Survey
Visit 2 (Baseline) Physical Component Summary
|
35.4 Scores on a scales
Standard Deviation 7.8
|
35.7 Scores on a scales
Standard Deviation 8.1
|
|
Short Form (SF-36) Health Survey
Visit 6 (Day 364) Physical Component Summary
|
39.6 Scores on a scales
Standard Deviation 9.6
|
41.6 Scores on a scales
Standard Deviation 10.1
|
|
Short Form (SF-36) Health Survey
Visit 9 (Day 728) Physical Component Summary
|
41.8 Scores on a scales
Standard Deviation 9.5
|
42.2 Scores on a scales
Standard Deviation 10.0
|
|
Short Form (SF-36) Health Survey
Visit 2 (Baseline) Mental Component Summary
|
51.7 Scores on a scales
Standard Deviation 9.5
|
52.7 Scores on a scales
Standard Deviation 11.0
|
|
Short Form (SF-36) Health Survey
Visit 6 (Day 364) Mental Component Summary
|
53.2 Scores on a scales
Standard Deviation 9.0
|
54.0 Scores on a scales
Standard Deviation 10.7
|
|
Short Form (SF-36) Health Survey
Visit 9 (Day 728) Mental Component Summary
|
52.7 Scores on a scales
Standard Deviation 9.2
|
56.0 Scores on a scales
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, 12 months (Day 364) and 24 months (Day 728)Population: Intention-To-Treat
Study knees were evaluated at each visit for the presence or absence of swelling and effusion.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Percentage of Participants With Presence of Joint Swelling and Effusion
Baseline
|
60.8 percentage of participants
|
56.7 percentage of participants
|
|
Percentage of Participants With Presence of Joint Swelling and Effusion
Visit 9 (Day 728)
|
10.3 percentage of participants
|
17.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)Population: Intention-To-Treat
Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit. Daily consumption of acetaminophen was calculated as an average.
Outcome measures
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 Participants
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib (Celebrex)
n=97 Participants
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Use of Acetaminophen
|
1.17 Daily number of caplets taken
Standard Deviation 1.43
|
0.94 Daily number of caplets taken
Standard Deviation 1.61
|
Adverse Events
Chondroitin Sulfate (Condrosan)
Celecoxib
Serious adverse events
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 participants at risk
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib
n=97 participants at risk
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Infections and infestations
Morganella Infection
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.0%
1/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip And/Or Oral Cavity Cancer
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Surgical and medical procedures
Cataract Operation
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Surgical and medical procedures
Hip Surgery
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Surgical and medical procedures
Hysterectomy
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
|
Gastrointestinal disorders
Proctocolitis
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Injury, poisoning and procedural complications
Post Procedural Haematuria
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Cardiac disorders
Sinus Arrhythmia
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Renal and urinary disorders
Bladder Perforation
|
1.0%
1/97 • 2 years
|
0.00%
0/97 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/97 • 2 years
|
1.0%
1/97 • 2 years
|
Other adverse events
| Measure |
Chondroitin Sulfate (Condrosan)
n=97 participants at risk
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period
|
Celecoxib
n=97 participants at risk
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.6%
19/97 • 2 years
|
14.4%
14/97 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.5%
17/97 • 2 years
|
5.2%
5/97 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.2%
6/97 • 2 years
|
8.2%
8/97 • 2 years
|
|
Infections and infestations
Nasopharyngitis
|
28.9%
28/97 • 2 years
|
18.6%
18/97 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
12.4%
12/97 • 2 years
|
12.4%
12/97 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.2%
5/97 • 2 years
|
5.2%
5/97 • 2 years
|
|
Nervous system disorders
Headache
|
15.5%
15/97 • 2 years
|
10.3%
10/97 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.2%
5/97 • 2 years
|
6.2%
6/97 • 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
18.6%
18/97 • 2 years
|
18.6%
18/97 • 2 years
|
|
General disorders
General disorders and administration site conditions
|
12.4%
12/97 • 2 years
|
12.4%
12/97 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
3.1%
3/97 • 2 years
|
11.3%
11/97 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders
|
4.1%
4/97 • 2 years
|
9.3%
9/97 • 2 years
|
|
Investigations
Investigations
|
6.2%
6/97 • 2 years
|
6.2%
6/97 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures
|
8.2%
8/97 • 2 years
|
8.2%
8/97 • 2 years
|
|
Vascular disorders
Vascular disorders
|
7.2%
7/97 • 2 years
|
5.2%
5/97 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
30.9%
30/97 • 2 years
|
33.0%
32/97 • 2 years
|
|
Infections and infestations
Infections and infestations
|
39.2%
38/97 • 2 years
|
44.3%
43/97 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
20.6%
20/97 • 2 years
|
27.8%
27/97 • 2 years
|
|
Nervous system disorders
Nervous system disorders
|
6.2%
6/97 • 2 years
|
12.4%
12/97 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
14.4%
14/97 • 2 years
|
14.4%
14/97 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60