Trial Outcomes & Findings for Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee (NCT NCT00955552)
NCT ID: NCT00955552
Last Updated: 2023-02-08
Results Overview
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
approximately 5 months
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Cosamin DS®
|
Glucosamine/Chondroitin Sulphate
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
Baseline characteristics by cohort
| Measure |
Cosamin DS®
n=44 Participants
|
Glucosamine/Chondroitin Sulphate
n=45 Participants
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
Total
n=89 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
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: In this section the population analyzed was per protocol (PP).
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.
Outcome measures
| Measure |
Cosamin DS®
n=41 Participants
Cosamin DS® (Nutramax): oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
|
Glucosamine/Chondroitin Sulphate
n=45 Participants
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
Glucosamine sulphate and chondroitin sulphate association: glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
|
|---|---|---|
|
To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form
|
85.4 percentage of participants
Interval 70.1 to 93.4
|
88.9 percentage of participants
Interval 75.2 to 95.8
|
Adverse Events
Cosamin DS®
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Glucosamine/Chondroitin Sulphate
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cosamin DS®
n=50 participants at risk
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
Glucosamine/Chondroitin Sulphate
n=50 participants at risk
Glucosamine 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arm fracture
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Shoulder fracture
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Heart attack
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
Cosamin DS®
n=50 participants at risk
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
Glucosamine/Chondroitin Sulphate
n=50 participants at risk
Glucosamine 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
|
|---|---|---|
|
General disorders
headache
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
6.0%
3/50 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Nausea
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Endocrine disorders
Worsening Diabetes Mellitus
|
2.0%
1/50 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Endocrine disorders
dyspepsia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Epigastralgia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Additional Information
Eurofarma Laboratórios
Eurofarma Laboratórios
Phone: 08007043876
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place