Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee (NCT NCT01768520)
NCT ID: NCT01768520
Last Updated: 2019-07-02
Results Overview
Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome. Range of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0\~68) Higher scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
338 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Entelon Tab. 150mg
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
152
|
147
|
39
|
|
Overall Study
COMPLETED
|
120
|
121
|
30
|
|
Overall Study
NOT COMPLETED
|
32
|
26
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Entelon Tab. 150mg
n=152 Participants
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
n=147 Participants
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
n=39 Participants
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.41 years
STANDARD_DEVIATION 7.41 • n=152 Participants
|
62.24 years
STANDARD_DEVIATION 7.12 • n=147 Participants
|
64.13 years
STANDARD_DEVIATION 6.76 • n=39 Participants
|
62.09 years
STANDARD_DEVIATION 7.24 • n=338 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=152 Participants
|
105 Participants
n=147 Participants
|
31 Participants
n=39 Participants
|
260 Participants
n=338 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=152 Participants
|
42 Participants
n=147 Participants
|
8 Participants
n=39 Participants
|
78 Participants
n=338 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
152 participants
n=152 Participants
|
147 participants
n=147 Participants
|
39 participants
n=39 Participants
|
338 participants
n=338 Participants
|
|
Part of Osteoarthritis diagnosis
Right knee
|
72 participants
n=152 Participants
|
70 participants
n=147 Participants
|
17 participants
n=39 Participants
|
159 participants
n=338 Participants
|
|
Part of Osteoarthritis diagnosis
Left knee
|
80 participants
n=152 Participants
|
77 participants
n=147 Participants
|
22 participants
n=39 Participants
|
179 participants
n=338 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksRange of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome. Range of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0\~68) Higher scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Outcome measures
| Measure |
Entelon Tab. 150mg
n=120 Participants
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
n=121 Participants
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
n=30 Participants
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
|---|---|---|---|
|
the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
baseline
|
51.64 score on a scale
Standard Deviation 13.62
|
54.57 score on a scale
Standard Deviation 14.06
|
49.94 score on a scale
Standard Deviation 11.81
|
|
the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
12 weeks
|
30.68 score on a scale
Standard Deviation 18.69
|
33.88 score on a scale
Standard Deviation 20.44
|
33.80 score on a scale
Standard Deviation 15.98
|
|
the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
change(12 weeks-baseline)
|
-19.38 score on a scale
Standard Deviation 19.79
|
-19.26 score on a scale
Standard Deviation 18.22
|
-16.70 score on a scale
Standard Deviation 20.10
|
SECONDARY outcome
Timeframe: baseline and 12 weeksNumeric Rating Scale is 10 point scale(0\~10 score). 0 score: no pain, 10 score: worst possible pain If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Outcome measures
| Measure |
Entelon Tab. 150mg
n=120 Participants
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
n=121 Participants
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
n=30 Participants
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
|---|---|---|---|
|
the Change of Numeric Rating Scale
12 weeks
|
3.57 score on a scale
Standard Deviation 2.07
|
4.09 score on a scale
Standard Deviation 2.09
|
4.23 score on a scale
Standard Deviation 2.22
|
|
the Change of Numeric Rating Scale
baseline
|
5.62 score on a scale
Standard Deviation 1.40
|
5.54 score on a scale
Standard Deviation 1.73
|
5.44 score on a scale
Standard Deviation 1.67
|
|
the Change of Numeric Rating Scale
change(12weeks-baseline)
|
-2.14 score on a scale
Standard Deviation 1.81
|
-1.54 score on a scale
Standard Deviation 2.34
|
-1.50 score on a scale
Standard Deviation 1.86
|
Adverse Events
Entelon Tab. 150mg
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Celebrex Cap.
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entelon Tab. 150mg
n=152 participants at risk
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
n=147 participants at risk
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
n=39 participants at risk
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Eye disorders
Nasolacrimal duct obstruction,Right
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Gastrointestinal disorders
Epigastric pain
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
0.00%
0/152 • 12Weeks
|
0.68%
1/147 • Number of events 1 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/152 • 12Weeks
|
0.68%
1/147 • Number of events 1 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Nervous system disorders
Middle cerebral artery stenosis
|
0.00%
0/152 • 12Weeks
|
0.68%
1/147 • Number of events 1 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Infections and infestations
three abscess cavities scattered in both hepatic lobes
|
0.00%
0/152 • 12Weeks
|
0.68%
1/147 • Number of events 1 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/152 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
Other adverse events
| Measure |
Entelon Tab. 150mg
n=152 participants at risk
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
|
Celebrex Cap.
n=147 participants at risk
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
Placebo
n=39 participants at risk
Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/152 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.9%
6/152 • Number of events 6 • 12Weeks
|
2.0%
3/147 • Number of events 3 • 12Weeks
|
5.1%
2/39 • Number of events 2 • 12Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
2.0%
3/147 • Number of events 3 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/152 • 12Weeks
|
1.4%
2/147 • Number of events 2 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/152 • Number of events 3 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/152 • 12Weeks
|
2.0%
3/147 • Number of events 3 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
3.4%
5/147 • Number of events 5 • 12Weeks
|
0.00%
0/39 • 12Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
1/152 • Number of events 1 • 12Weeks
|
1.4%
2/147 • Number of events 2 • 12Weeks
|
5.1%
2/39 • Number of events 2 • 12Weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/152 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
5.1%
2/39 • Number of events 2 • 12Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/152 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
7.7%
3/39 • Number of events 3 • 12Weeks
|
|
Nervous system disorders
Headache
|
1.3%
2/152 • Number of events 2 • 12Weeks
|
1.4%
2/147 • Number of events 2 • 12Weeks
|
5.1%
2/39 • Number of events 2 • 12Weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/152 • 12Weeks
|
0.00%
0/147 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/152 • 12Weeks
|
1.4%
2/147 • Number of events 2 • 12Weeks
|
2.6%
1/39 • Number of events 1 • 12Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place