Trial Outcomes & Findings for Phase III Study of CG100649 in Osteoarthritis Patients (NCT NCT01765296)
NCT ID: NCT01765296
Last Updated: 2023-02-15
Results Overview
Western Ontario and McMaster Universities (WOMAC) OA index. Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language will be used for each site enrolled in the trial. The numerical rating scale version of the WOMAC-Pain subscale was used, i.e., with the subject assessing each question by a 11-point (0-10) numerical rating scale, and the total pain score being represented by the sum of the 5 component item scores. A higher WOMAC score represented worse symptom severity, with 50 being the worst possible total score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
CG100649
CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)
|
Celecoxib
Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
146
|
145
|
|
Overall Study
COMPLETED
|
66
|
126
|
132
|
|
Overall Study
NOT COMPLETED
|
5
|
20
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
CG100649
CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)
|
Celecoxib
Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
13
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
Baseline Characteristics
Phase III Study of CG100649 in Osteoarthritis Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=71 Participants
Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
CG100649
n=146 Participants
CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)
|
Celecoxib
n=145 Participants
Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 7.52 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat (ITT) population (Baseline Observation Carried Forward (BOCF))
Western Ontario and McMaster Universities (WOMAC) OA index. Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language will be used for each site enrolled in the trial. The numerical rating scale version of the WOMAC-Pain subscale was used, i.e., with the subject assessing each question by a 11-point (0-10) numerical rating scale, and the total pain score being represented by the sum of the 5 component item scores. A higher WOMAC score represented worse symptom severity, with 50 being the worst possible total score.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
CG100649 2 mg
n=146 Participants
CG100649 2 mg capsule administered orally, once a day for 6 weeks (Treatment Phase); for 18 weeks (Safety Phase)
|
Celecoxib 200 mg
n=145 Participants
Celecoxib 200 mg administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
|---|---|---|---|
|
Change in WOMAC-Pain Subscale
Baseline
|
26.8 units on a scale
Standard Deviation 4.58
|
27.9 units on a scale
Standard Deviation 5.01
|
27.7 units on a scale
Standard Deviation 5.08
|
|
Change in WOMAC-Pain Subscale
Week 6
|
24.2 units on a scale
Standard Deviation 7.41
|
22.7 units on a scale
Standard Deviation 8.71
|
21.9 units on a scale
Standard Deviation 7.65
|
|
Change in WOMAC-Pain Subscale
Change From Baseline
|
-2.5 units on a scale
Standard Deviation 6.73
|
-5.3 units on a scale
Standard Deviation 7.11
|
-5.8 units on a scale
Standard Deviation 6.67
|
SECONDARY outcome
Timeframe: Baseline, Week 3 and Week 6Population: Intent-to-Treat (ITT) (BOCF)
Western Ontario and McMaster Universities (WOMAC) OA index. Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language will be used for each site enrolled in the trial. The 24 questions, which measure with 0-10 point numerical rating scale (NRS) with a maximum of 240 points to evaluate "Pain (5 questions)," "Stiffness (2 questions)," and "Physical Function (17 questions)" in WOMAC 3.1. Total scores for WOMAC-physical function is from 0 to 170 points. A higher WOMAC score represented worse symptom severity.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
CG100649 2 mg
n=146 Participants
CG100649 2 mg capsule administered orally, once a day for 6 weeks (Treatment Phase); for 18 weeks (Safety Phase)
|
Celecoxib 200 mg
n=145 Participants
Celecoxib 200 mg administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
|---|---|---|---|
|
Change of the WOMAC-physical Function Subscale at Week 3 and 6 From Pre-dose Baseline
Week 3
|
-5.7 units on a scale
Interval -10.6 to -0.8
|
-13.7 units on a scale
Interval -17.5 to -9.9
|
-10.7 units on a scale
Interval -14.5 to -6.9
|
|
Change of the WOMAC-physical Function Subscale at Week 3 and 6 From Pre-dose Baseline
Week 6
|
-7.9 units on a scale
Interval -13.4 to -2.3
|
-14.3 units on a scale
Interval -18.6 to -10.0
|
-14.9 units on a scale
Interval -19.1 to -10.6
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CG100649
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Celecoxib
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=71 participants at risk
Placebo administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
CG100649
n=146 participants at risk
CG100649 2 mg capsule administered orally, once a day for 6 weeks (Treatment Phase); for 18 weeks (Safety Phase)
|
Celecoxib
n=145 participants at risk
Celecoxib 200 mg administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma (Villotubular adenoma)
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.68%
1/146 • Number of events 1 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
1.4%
1/71 • Number of events 1 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Injury, poisoning and procedural complications
Spinal compression Fracture
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.68%
1/146 • Number of events 1 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.69%
1/145 • Number of events 1 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
Other adverse events
| Measure |
Placebo
n=71 participants at risk
Placebo administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
CG100649
n=146 participants at risk
CG100649 2 mg capsule administered orally, once a day for 6 weeks (Treatment Phase); for 18 weeks (Safety Phase)
|
Celecoxib
n=145 participants at risk
Celecoxib 200 mg administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
2.1%
3/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
2.1%
3/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
4.8%
7/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
3.4%
5/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
1/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.68%
1/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
2.8%
4/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
General disorders
Oedema Peripheral
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
4.8%
7/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
2.1%
3/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.8%
2/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
2/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.68%
1/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/71 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
2.1%
3/146 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
0.00%
0/145 • From ICF to Treatment Completion, up to 6 months (24weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
- Publication restrictions are in place
Restriction type: OTHER