Trial Outcomes & Findings for Study of CG100649 Versus Celecoxib in Osteoarthritis Patients (NCT NCT01341405)
NCT ID: NCT01341405
Last Updated: 2023-02-09
Results Overview
Changes in the WOMAC Pain Score from Baseline The primary endpoint of this study was the change in the sum of the WOMAC Pain subscale at Day 28 vs. Baseline (Day 1) using the ITT population). Pain scores were evaluated using the WOMAC Pain subscale, which provided an evaluation of pain during the past 48 hours using a 0-10 numerical rating scale for each of 5 questions (minimum total: 0 point, maximum total: 50 points). A higher WOMAC Pain score represented worse symptom severity.
COMPLETED
PHASE2
125 participants
Baseline, Day 28
2023-02-09
Participant Flow
The study was conducted from Apr 2011 to Dec 2011 in 5 sites in Korea.
Participant milestones
| Measure |
CG100649 2 mg
once daily for 28 days
|
CG100649 4 mg
once daily for 28 days
|
Celecoxib 200 mg
once daily for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
43
|
|
Overall Study
COMPLETED
|
37
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
CG100649 2 mg
once daily for 28 days
|
CG100649 4 mg
once daily for 28 days
|
Celecoxib 200 mg
once daily for 28 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
Baseline Characteristics
Study of CG100649 Versus Celecoxib in Osteoarthritis Patients
Baseline characteristics by cohort
| Measure |
CG100649 2 mg
n=40 Participants
once daily for 28 days
|
CG100649 4 mg
n=42 Participants
once daily for 28 days
|
Celecoxib 200 mg
n=43 Participants
once daily for 28 days
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
62.1 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
59 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
61 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 7.79 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28Population: intent-to-treat population (BOCF)
Changes in the WOMAC Pain Score from Baseline The primary endpoint of this study was the change in the sum of the WOMAC Pain subscale at Day 28 vs. Baseline (Day 1) using the ITT population). Pain scores were evaluated using the WOMAC Pain subscale, which provided an evaluation of pain during the past 48 hours using a 0-10 numerical rating scale for each of 5 questions (minimum total: 0 point, maximum total: 50 points). A higher WOMAC Pain score represented worse symptom severity.
Outcome measures
| Measure |
CG100649 2mg
n=40 Participants
once daily for 28 days
|
CG100649 4mg
n=42 Participants
once daily for 28 days
|
Celecoxib 200 mg
n=43 Participants
once daily for 28 days
|
|---|---|---|---|
|
Change of the WOMAC Pain Subscale at Day 28 From Baseline
|
-14.33 units on a scale
Interval -16.7 to -11.97
|
-12.47 units on a scale
Interval -14.89 to -10.05
|
-13.24 units on a scale
Interval -15.73 to -10.76
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: intent-to-treat population (BOCF)
The numerical rating scale version of the Western Ontario and McMaster Universities (WOMAC) OA index will be used-i.e., with the patient assessing each question by a 11-point (0-10) numerical rating scale, and the total index score being represented by the sum of the 24 component item scores. A higher WOMAC score represents worse symptom severity, with 240 being the worst possible total score (minimum total: 0 point, maximum total: 240 points).
Outcome measures
| Measure |
CG100649 2mg
n=40 Participants
once daily for 28 days
|
CG100649 4mg
n=42 Participants
once daily for 28 days
|
Celecoxib 200 mg
n=43 Participants
once daily for 28 days
|
|---|---|---|---|
|
Change of the Sum of WOMAC OA Index at Day 28 From Baseline
|
-49.94 units on a scale
Interval -60.65 to -39.23
|
-41.61 units on a scale
Interval -52.81 to -30.4
|
-43.80 units on a scale
Interval -53.52 to -34.09
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: intent-to-treat population (BOCF)
Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language was used to evaluate the stiffness of the index joint. Two questions were to evaluate "Stiffness" of the index joint. A higher WOMAC-Stiffness score represents worse symptom severity, with 20 being the worst possible total score (minimum total: 0 point, maximum total: 20 points).
Outcome measures
| Measure |
CG100649 2mg
n=40 Participants
once daily for 28 days
|
CG100649 4mg
n=42 Participants
once daily for 28 days
|
Celecoxib 200 mg
n=43 Participants
once daily for 28 days
|
|---|---|---|---|
|
Change of WOMAC-Stiffness Subscale at Day 28 From Baseline
|
-3.17 units on a scale
Interval -4.33 to -2.0
|
-2.87 units on a scale
Interval -4.02 to -1.71
|
-2.32 units on a scale
Interval -3.29 to -1.34
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: intent-to-treat population (BOCF)
Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language was used. The total 17 questions to evaluate "Physical Function." A higher score of WOMAC-Physical function subscale represents worse symptom severity, with 170 being the worst possible total score (minimum total: 0 point, maximum total: 170 points).
Outcome measures
| Measure |
CG100649 2mg
n=40 Participants
once daily for 28 days
|
CG100649 4mg
n=42 Participants
once daily for 28 days
|
Celecoxib 200 mg
n=43 Participants
once daily for 28 days
|
|---|---|---|---|
|
Change of WOMAC-Physical Function Subscale at Day 28 From Baseline
|
-32.44 units on a scale
Interval -40.44 to -24.45
|
-26.26 units on a scale
Interval -34.77 to -17.75
|
-28.24 units on a scale
Interval -35.47 to -21.02
|
Adverse Events
CG100649 2mg
CG100649 4mg,
Celecoxib 200mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CG100649 2mg
n=40 participants at risk
once daily for 28 days
|
CG100649 4mg,
n=42 participants at risk
once daily for 28 days
|
Celecoxib 200mg
n=43 participants at risk
once daily for 28 dyas
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.5%
3/40 • Number of events 3 • from ICF to treatment completion
|
14.3%
6/42 • Number of events 6 • from ICF to treatment completion
|
7.0%
3/43 • Number of events 3 • from ICF to treatment completion
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
4/40 • Number of events 4 • from ICF to treatment completion
|
21.4%
9/42 • Number of events 9 • from ICF to treatment completion
|
7.0%
3/43 • Number of events 3 • from ICF to treatment completion
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • Number of events 3 • from ICF to treatment completion
|
2.4%
1/42 • Number of events 1 • from ICF to treatment completion
|
7.0%
3/43 • Number of events 3 • from ICF to treatment completion
|
|
General disorders
chest discomfort
|
0.00%
0/40 • from ICF to treatment completion
|
7.1%
3/42 • Number of events 3 • from ICF to treatment completion
|
0.00%
0/43 • from ICF to treatment completion
|
|
General disorders
face edema
|
2.5%
1/40 • Number of events 1 • from ICF to treatment completion
|
7.1%
3/42 • Number of events 3 • from ICF to treatment completion
|
0.00%
0/43 • from ICF to treatment completion
|
|
Infections and infestations
Oropharyngeal pain
|
5.0%
2/40 • Number of events 2 • from ICF to treatment completion
|
0.00%
0/42 • from ICF to treatment completion
|
2.3%
1/43 • Number of events 1 • from ICF to treatment completion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication requires prior expressed written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER