Trial Outcomes & Findings for Effects Of Native Collagen Type 2 Treatment (NCT NCT02237989)
NCT ID: NCT02237989
Last Updated: 2020-09-18
Results Overview
Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
3 months
Results posted on
2020-09-18
Participant Flow
Participant milestones
| Measure |
Paracetamol
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects Of Native Collagen Type 2 Treatment
Baseline characteristics by cohort
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.84 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
57.65 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPost treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
Outcome measures
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
|
3 score on a scale
Interval 0.0 to 9.0
|
3 score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 3 monthsPost treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.
Outcome measures
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
|
52 units on a scale
Interval 24.0 to 100.0
|
44 units on a scale
Interval 24.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 monthsPost treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
Outcome measures
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
the Change From Baseline in 20 Meters Walking Time
|
18.84 seconds
Standard Deviation 4.79
|
18 seconds
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: 3 monthsPost treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better
Outcome measures
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
|
51 score
Interval 10.0 to 100.0
|
52 score
Interval 10.0 to 84.0
|
SECONDARY outcome
Timeframe: 3 monthsPost treatment comparison of Coll2-1 levels between groups
Outcome measures
| Measure |
Paracetamol
n=19 Participants
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg
|
Native Collagen Type 2 + Paracetamol
n=20 Participants
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)
|
|---|---|---|
|
the Change From Baseline in Coll2-1 Levels
|
130 microgram/ml
Interval 22.4 to 596.13
|
155.25 microgram/ml
Interval 26.84 to 558.01
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place