NCT01768520

Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

Completed Phase 3 Results posted Last updated 2 July 2019

What this trial tests

Phase 3 trial testing Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks in Knee Osteoarthritis in 338 participants. Completed in 13 May 2015.

Timeline

2 July 2012

Primary endpoint
15 October 2014

13 May 2015

Quick facts

Lead sponsor	Hanlim Pharm. Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	338
Start date	2 July 2012
Primary completion	15 October 2014
Estimated completion	13 May 2015
Sites	1 location across South Korea

Drugs / interventions tested

• Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks — full drug profile →
• Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks — full drug profile →
• Placebo

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Hanlim Pharm. Co., Ltd. — full company profile →

Who can join

Adults 35 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) Primary · baseline and 12 weeks

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.

baseline

Group	Value	95% CI
Entelon Tab. 150mg	51.64	± 13.62
Celebrex Cap.	54.57	± 14.06
Placebo	49.94	± 11.81

12 weeks

Group	Value	95% CI
Entelon Tab. 150mg	30.68	± 18.69
Celebrex Cap.	33.88	± 20.44
Placebo	33.80	± 15.98

change(12 weeks-baseline)

Group	Value	95% CI
Entelon Tab. 150mg	-19.38	± 19.79
Celebrex Cap.	-19.26	± 18.22
Placebo	-16.70	± 20.10

the Change of Numeric Rating Scale Secondary · baseline and 12 weeks

Numeric 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.

baseline

Group	Value	95% CI
Entelon Tab. 150mg	5.62	± 1.40
Celebrex Cap.	5.54	± 1.73
Placebo	5.44	± 1.67

12 weeks

Group	Value	95% CI
Entelon Tab. 150mg	3.57	± 2.07
Celebrex Cap.	4.09	± 2.09
Placebo	4.23	± 2.22

change(12weeks-baseline)

Group	Value	95% CI
Entelon Tab. 150mg	-2.14	± 1.81
Celebrex Cap.	-1.54	± 2.34
Placebo	-1.50	± 1.86

Adverse events — posted to ClinicalTrials.gov

Time frame: 12Weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Entelon Tab. 150mg

Serious: 3/152 (2%)

Deaths: 0/152

Celebrex Cap.

Serious: 4/147 (3%)

Deaths: 0/147

Placebo

Serious: 1/39 (3%)

Deaths: 0/39

Serious adverse events (8 terms)

Reaction	System	Entelon Tab. 150mg	Celebrex Cap.	Placebo
Multiple fractures	Injury, poisoning and procedural complications	—	—	—
Nasolacrimal duct obstruction,Right	Eye disorders	—	—	—
Epigastric pain	Gastrointestinal disorders	—	—	—
Esophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Hemorrhoids	Gastrointestinal disorders	—	—	—
Middle cerebral artery stenosis	Nervous system disorders	—	—	—
three abscess cavities scattered in both hepatic lobes	Infections and infestations	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Entelon Tab. 150mg	Celebrex Cap.	Placebo
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Herpes zoster	Infections and infestations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Nocturia	Renal and urinary disorders	—	—	—

Most-reported serious reactions: Multiple fractures, Nasolacrimal duct obstruction,Right, Epigastric pain, Esophageal cancer, Hemorrhoids, Middle cerebral artery stenosis, three abscess cavities scattered in both hepatic lobes, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT01768520 adverse events section.

Sponsor's own description

This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Celecoxib for osteoarthritis.
   Puljak L, Marin A, Vrdoljak D, Markotic F, et al · · 2017 · cited 73× · PMID 28530031 · DOI 10.1002/14651858.cd009865.pub2
2. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8