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Table 3 Evaluation of joint pain and swelling and of the use of rescue therapy per visit in ITT population (N = 89)

From: Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis

 

Glucosamine sulfate and chondroitin sulfate (n = 45)

Cosamin DS® (n = 44)

N

%

N

%

p-value

Absence of pain at joint pain evaluation

V1 (Baseline)

1

2,2

3

6,8

0.361

V2 (Day 37)

6

13,3

8

18,2

0.573

V3 (Day 67)

10

22,2

8

18,2

0.793

V4 (Day 97)

17

37,8

17

38,6

> 0.999

V5 (Day 127)

30

66,7

23

52,3

0.198

Absence of joint swelling

V1 (Baseline)

37

82,2

36

81,8

> 0.999

V2 (Day 37)

37

82,2

37

84,1

> 0.999

V3 (Day 67)

41

91,1

36

81,8

0.230

V4 (Day 97)

42

93,3

39

88,6

0.485

V5 (Day 127)

44

97,8

42

95,5

0.616

Joint pain evaluation

 No pain

V1 (Baseline)

1

2,2

3

6,8

0.361

V2 (Day 37)

6

13,3

8

18,2

0.573

V3 (Day 67)

10

22,2

8

18,2

0.793

V4 (Day 97)

17

37,8

17

38,6

> 0.999

V5 (Day 127)

30

66,7

23

52,3

0.198

Subject reports pain

V1 (Baseline)

22

48,9

19

43,2

0.672

V2 (Day 37)

28

62,3

25

56,8

0.669

V3 (Day 67)

22

48,9

27

61,4

0.289

V4 (Day 97)

20

44,4

20

45,5

> 0.999

V5 (Day 127)

9

20,0

25

34,1

< 0.001

 Subject reports pain and changes facial expression

V1 (Baseline)

20

44,4

20

45,5

> 0.999

V2 (Day 37)

11

24,4

9

20,5

0.800

V3 (Day 67)

12

26,7

8

18,2

0.448

V4 (Day 97)

8

17,8

6

13,6

0.772

V5 (Day 127)

6

13,3

6

13,6

> 0.999

 Subject reports pain, changes facial expression and makes moves to cut limb

V1 (Baseline)

2

4,4

2

4,5

> 0.999

V2 (Day 37)

0

0

2

4,5

0.242

V3 (Day 67)

1

2,2

1

2,3

> 0.999

V4 (Day 97)

0

0

1

2,3

0.494

V5 (Day 127)

0

0

0

0

> 0.999

 Subjects receiving rescue medication

V2 (Day 37)

39

86,7

40

90,9

0.739

V3 (Day 67)

41

91,1

36

81,8

0.230

V4 (Day 97)

41

91,1

38

86,4

0.522

V5 (Day 127)

36

80,0

33

75,0

0.619

 Quantity of rescue medication tablets taken (average ± SD)

V2 (Day 37)

19,21 ± 16,52

 

13,95 ± 13,73

 

0.109

V3 (Day 67)

17,24 ± 13,55

 

13,11 ± 14,79

 

0.148

V4 (Day 97)

15,37 ± 12,28

 

12,87 ± 14,57

 

0.351

V5 (Day 127)

14,81 ± 10,92

 

15,09 ± 12,57

 

0.920

  1. SD standard deviation, ITT intention to treat, V visit