Knee Osteoarthritis
Conditions
Brief summary
The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.
Detailed description
The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.
Interventions
DRUGCS+SG
Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
DRUGPlacebo
Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Sponsors
Tedec-Meiji Farma, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient \>= 45 years . * Primary OA of the knee according to ACR criteria. * OA radiological grade II-III according to Kellgren and Lawrence. * Patients with moderate-severe pain.
Exclusion criteria
* Patients with clinical significant trauma or surgery in the target knee. * Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia. * Pain in other parts of the body greater than the knee pain that could interfere with the evaluation. * Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections. * Clinical diagnosis established of uncontrolled diabetes mellitus. * Patients with asthma. * History of hypersensitivity to the active drugs or any excipients of the formulations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain According to VAS (0-100 mm) | 24 weeks | 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). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CS+SG Chondroitin sulfate+glucosamine sulfate | 80 |
| Placebo Placebo oral | 78 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 3 |
| Overall Study | Lack of adherence to treatment | 2 | 0 |
| Overall Study | Lack of Efficacy | 5 | 7 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other reason | 1 | 3 |
| Overall Study | Protocol Violation | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CS+SG | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 65.49 years STANDARD_DEVIATION 8.17 | 67.60 years STANDARD_DEVIATION 8.9 | 66.53 years STANDARD_DEVIATION 8.58 |
| Sex: Female, Male Female | 65 Participants | 67 Participants | 132 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 80 | 18 / 78 |
| serious Total, serious adverse events | 2 / 80 | 2 / 78 |
Outcome results
Primary
Change in Pain According to VAS (0-100 mm)
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).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CS+SG | Change in Pain According to VAS (0-100 mm) | -11.86 units on a scale | Standard Deviation 2.42 |
| Placebo | Change in Pain According to VAS (0-100 mm) | -20.57 units on a scale | Standard Deviation 2.41 |
p-value: <0.0307Pocock approach