Trial Outcomes & Findings for Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis (NCT NCT01893905)
NCT ID: NCT01893905
Last Updated: 2017-08-04
Results Overview
VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).
COMPLETED
PHASE3
158 participants
24 weeks
2017-08-04
Participant Flow
Participant milestones
| Measure |
CS+SG
Chondroitin sulfate+ glucosamine sulfate
|
Placebo
Oral Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
78
|
|
Overall Study
COMPLETED
|
55
|
64
|
|
Overall Study
NOT COMPLETED
|
25
|
14
|
Reasons for withdrawal
| Measure |
CS+SG
Chondroitin sulfate+ glucosamine sulfate
|
Placebo
Oral Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
6
|
1
|
|
Overall Study
Lack of adherence to treatment
|
2
|
0
|
|
Overall Study
Other reason
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
CS+SG
n=80 Participants
Chondroitin sulfate+glucosamine sulfate
|
Placebo
n=78 Participants
Placebo oral
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.49 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
67.60 years
STANDARD_DEVIATION 8.90 • n=7 Participants
|
66.53 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksVAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).
Outcome measures
| Measure |
CS+SG
n=80 Participants
Chondroitin sulfate+glucosamine sulfate
|
Placebo
n=78 Participants
Placebo Oral
|
|---|---|---|
|
Change in Pain According to VAS (0-100 mm)
|
-11.86 units on a scale
Standard Deviation 2.42
|
-20.57 units on a scale
Standard Deviation 2.41
|
Adverse Events
CS+SG
Placebo
Serious adverse events
| Measure |
CS+SG
n=80 participants at risk
chondroitin sulfate+glucosamine sulfate
|
Placebo
n=78 participants at risk
Placebo oral
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/78 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/80 • 6 months
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/78 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/80 • 6 months
|
1.3%
1/78 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
CS+SG
n=80 participants at risk
chondroitin sulfate+glucosamine sulfate
|
Placebo
n=78 participants at risk
Placebo oral
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
7/80 • Number of events 7 • 6 months
|
5.1%
4/78 • Number of events 4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
4/80 • Number of events 4 • 6 months
|
3.8%
3/78 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
2/80 • Number of events 2 • 6 months
|
5.1%
4/78 • Number of events 4 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/80 • Number of events 1 • 6 months
|
7.7%
6/78 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
4/80 • Number of events 4 • 6 months
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
5.0%
4/80 • Number of events 4 • 6 months
|
0.00%
0/78 • 6 months
|
Additional Information
Dr Francisco Blanco, study coordinator
Complejo Hospitalario de La Coruña (CHUAC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place