Knee OsteoarthritisPhase 3NCT01768520

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

A Phase 3 study testing Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks and Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks in people with Knee Osteoarthritis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks and Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 338 participants
Where: 1 siteSouth Korea
Study dates: 2 Jul 2012to 13 May 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

both gender,35 years ≤ age ≤ 75 years
patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the American College of Rheumatology clinical and radiographic criteria as follows.
knee arthralgia
more than one case among
50 years or over
morning stiffness less than 30 min

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friction sound
osteophyte in radiography
Kellgren and Lawrence Scale Grade II~III
total sum of K-WOMAC Scale more than 30
negative results in pregnancy test of urine in screening period
if women in childbearing age, medically reliable contraception or menopause
patients who give written consent of agreement to voluntarily participate in the clinical study
patients who can read and understand written instructions

Who cannot join

patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1
fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout
knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis
anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint
wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation
patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation

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severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma
medical history of malignant tumor
active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease
hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose
continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation
pregnant or lactating women
patients who have experience to participate in other clinical trial within 4 weeks prior to study participation
ALT, AST and Serum Creatinine ≥ 2×UNL
drug administration after diagnosing as alcoholic or psychical disease
patients whom the investigators judge as improper to participate in this clinical trial

Trial locations and contacts

1 site in 1 country.

South Korea1 site

The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Kyoung-gi Do, 420-717

Other trials in South Korea

About this study

Official title: For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)

Conditions: Knee Osteoarthritis
Being tested: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks, Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks, Placebo
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeksDrug
1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex
2. evening : 1 tab. of active Entelon 150mg
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeksDrug
1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex
2. evening : 1 tab. of placebo Entelon 150mg
PlaceboDrug
1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
2. evening : 1 tab. of placebo Entelon 150mg

Study groups in NCT01768520
Study group	Role	What they receive
Entelon tab. 150mg	Experimental	Not described Receives: Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks
Celebrex cap.	Active comparator	Not described Receives: Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

the Change of Numeric Rating Scale
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.
Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201213 May 2015

First posted15 Jan 2013 (estimated)
Study start2 Jul 2012
Primary completion15 Oct 2014
Study completion13 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 338 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01768520
Sponsor's protocol ID: HL_ENTR_302
Status last verified: Jun 2019
First submitted: 14 Jan 2013
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)
ClinicalTrials.gov ID: NCT01768520
Acronym / sponsor ID: HL_ENTR_302
Conditions: Knee Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 338 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Jul 2012 (actual)
Primary completion: 15 Oct 2014 (actual)
Study completion: 13 May 2015 (actual)
First posted: 15 Jan 2013 (estimated)
Results: Posted 24 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Entelon tab. 150mg	Experimental	Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks
Celebrex cap.	Active comparator	Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

both gender,35 years ≤ age ≤ 75 years
patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the American College of Rheumatology clinical and radiographic criteria as follows.
Kellgren and Lawrence Scale Grade II~III
total sum of K-WOMAC Scale more than 30
negative results in pregnancy test of urine in screening period

Key exclusion criteria (16 listed)

patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1
fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout
knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis
anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint
wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg	Drug	Entelon tab. 150mg
Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg	Drug	Celebrex cap.
Placebo1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg	Drug	Placebo

Primary outcome

the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
Time frame: 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.

1 secondary outcome

the Change of Numeric Rating Scale
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 24 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Entelon Tab. 150mg	152	120
Celebrex Cap.	147	121
Placebo	39	30

Primary outcome: the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Entelon Tab. 150mg n = 120	Celebrex Cap. n = 121	Placebo n = 30
baseline	51.64 (13.62)	54.57 (14.06)	49.94 (11.81)
12 weeks	30.68 (18.69)	33.88 (20.44)	33.80 (15.98)
change(12 weeks-baseline)	-19.38 (19.79)	-19.26 (18.22)	-16.70 (20.10)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12Weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Entelon Tab. 150mg	3 of 152 (2%)	14 of 152 (9.2%)	0 of 152
Celebrex Cap.	4 of 147 (2.7%)	22 of 147 (15%)	0 of 147
Placebo	1 of 39 (2.6%)	16 of 39 (41%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01768520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.