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Osteoarthritis of the KneePhase 3NCT01554163

Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis

A Phase 3 study testing Etoricoxib 30 mg and Celecoxib 200 mg in people with Osteoarthritis of the Knee, run by Organon and Co.

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

The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean patients. Given that the efficacy of etoricoxib vs. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
Etoricoxib 30 mg and Celecoxib 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
No sites listed yet
Study dates
Mar 2012to Mar 2013
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least 40 years of age
  • Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on clinical and radiographic criteria
  • Female patients of childbearing potential must have a negative pregnancy test prior to study enrollment and must agree to remain abstinent, and use barrier, intramuscular, or implanted contraceptives from Visit 1 until 28 days after the last dose of study medication.
  • Patient is of American Rheumatism Association (ARA) functional Class I, II, or III
  • Patient is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
  • Patient is willing to avoid unaccustomed physical activity for the duration of the study and follow-up period
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  • With the exception of osteoarthritis, the patient is judged to be in good general health based on medical history, physical exam, and routine laboratory tests
  • Patient is able to read, understand and complete study questionnaires, including questions requiring a visual analog scale (VAS) response
  • Patient provides written informed consent for the trial
  • For prior non-steroidal anti-inflammatory drug (NSAID) users only, the patient has a history of positive therapeutic benefit with NSAIDs and has taken an NSAID prior to study enrollment and at a therapeutic dose level prior to study enrollment (Visit 1)
  • For prior NSAID users only, the patient assessment of Pain Walking on a Flat Surface (WOMAC Section A, Question1) at Visit 1 (prestudy) is less than 80 mm (100 mm VAS)
  • For prior NSAID users only, prior to randomization, and following discontinuation of NSAIDs during the washout period specified patients must satisfy the following 3 flare criteria: Minimum of 40 mm on patient reported Pain Walking on a Flat Surface (WOMAC Section A, Question 1); Increase of 15 mm on patient reported Pain Walking on a Flat Surface (WOMAC Section A, Question 1) compared to prestudy baseline recorded at Visit 1; and A worsening in Investigator Global Assessment of Disease Status of at least 1 category on a 5 category scale compared to Visit 1 recording
  • For prior acetaminophen/paracetamol users only, patient has taken acetaminophen/paracetamol on a regular basis prior to study enrollment (Visit 1) and does not use NSAIDs for the treatment of osteoarthritis of the knee
  • For prior acetominophen/paracetamol users only, at both Visits 1 and 2, patients must satisfy all of the following 3 criteria: Minimum of 40 mm on patient reported Pain Walking on a Flat Surface (WOMAC Section A, Question 1); Investigator Global Assessment of Disease Status as fair, poor, or very poor; and Minimum of 40 mm on Patient Global Assessment of Disease Status (100 mm
  • VAS)

Who cannot join

  • Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
  • Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the investigator are sufficient to interfere with the conduct of the study
  • Patient has a history of gastric or biliary surgery (including gastric bypass surgery), or small intestine surgery that causes clinical malabsorption
  • Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or celecoxib or any of their constituents
  • Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs
  • Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min
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  • Patient has Class II-IV congestive heart failure
  • Patient has established ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
  • Patient has uncontrolled hypertension with an diastolic exclusionary limit of > 90 mm Hg and a systolic exclusionary limit of > 140 mm Hg
  • Patient has moderate or severe hepatic insufficiency defined as Child Pugh score > 6
  • Patient has a history of neoplastic disease
  • Patient has a history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
  • Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse or dependence
  • Patients considered morbidly obese with a body mass index (BMI) ≥ 35 kg/m^2
  • Patient has new use (within 2 weeks of Visit 1 and during the entire duration of the study and follow-up period) of physical medicine modalities involving the study joint, including but not limited to: physical therapy, chiropractic interventions, acupuncture, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound
  • Patient is expected to undergo surgery involving the study joint during the course of the study
  • Patients taking oral contraceptives
  • Patients using intra-articular steroids or hyaluronic acid injections to the study knee or other immunosuppressant medication within 3 months of Visit 1
  • Patients using intravenous, intramuscular, or oral corticosteroids, intra-articular steroids or hyaluronic acid injections to any joint other than the study joint within 1 month of Visit 1
  • Patients using topical or systemic analgesic medications within 3 days of Visit 1 and throughout the duration of the study
  • Patients using non-study NSAID or cyclooxygenase 2 (COX-2) specific inhibitor during the study treatment period, with the exception of low-dose aspirin (≤ 325 mg/day)
  • Patients receiving a Chinese traditional arthritis treatment within 1 week of Visit 1
  • Patients with clinically significant abnormalities on Visit 1 clinical examination or laboratory safety tests. Serum transaminases should be ≤ 150% of the upper limit of normal
  • Patients currently participating in or has participated in a study with an
  • investigational drug or device within 4 weeks of signing informed consent
  • Patients with an active peptic ulcer or a history of inflammatory bowel disease
  • Patients with a personal or family history of an inherited or acquired bleeding
  • Patients that are pregnant or breast-feeding, or expecting to conceive within the projected duration of the study

About this study

Official title: A Phase III, 12-Week, Randomized, Active-Comparator-Controlled, Parallel-Group, Double Blind Study in Korea to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis

The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of osteoarthritis has been established, and that prescription drugs, such as celecoxib, are available for the treatment of pain associated with osteoarthritis in Korea, it would be inappropriate to subject patients with a flare of osteoarthritic pain to the placebo treatment for 12 weeks, and thus the study is designed as an active-comparator study.

Being tested
Etoricoxib 30 mg, Celecoxib 200 mg
Keywords
Osteoarthritis, Celecoxib, Etoricoxib
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

  • Etoricoxib 30 mgDrug

    Also called MK-0663, Arcoxia

    Etoricoxib 30 mg tablet once daily for 12 weeks.

  • Celecoxib 200 mgDrug

    Also called Celebrex, Celebra

    Celecoxib 200 mg once daily for 12 weeks

Study groups in NCT01554163
Study groupRoleWhat they receive
Etoricoxib 30 mgExperimentalEtoricoxib, 30 mg tablet, orally, once daily for 12 weeks.
Receives: Drug: Etoricoxib 30 mg
Celecoxib 200 mgActive comparatorCelecoxib, 200 mg capsule, orally, once daily for 12 weeks.
Receives: Drug: Celecoxib 200 mg

What is being measured

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

  1. Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

    The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Baseline, Week 2, Week 6, Week 12

Secondary outcomes (6)

  1. Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale

    The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Baseline, Week 2, Week 6, Week 12

  2. Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status

    The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, "Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing." The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Baseline, Week 2, Week 6, Week 12

  3. Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy

    Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Week 2, Week 6, Week 12

  4. Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status

    Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Baseline, Week 2, Week 6, Week 12

  5. Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale

    The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Baseline, Week 2, Week 6, Week 12

  6. Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy

    Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.

    Measured: Week 6, Week 12

Timeline

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

  1. First posted14 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554163
Sponsor's protocol ID
0663-112
Status last verified
Feb 2022
First submitted
12 Mar 2012
Last updated
9 Feb 2022
Data monitoring committee
Yes

Publications

  • Yoo MC, Yoo WH, Kang SB, Park YW, Kim SS, Moon KH, Song YW, Min BW, Cho YJ, Moon SH, Bin SI, Baek HJ, Shim SC, Lee SW, Yoo DH, Mehta A, Skuban A, Cukrow DM, Vandormael K, Yan L. Etoricoxib in the treatment of Korean patients with osteoarthritis in a double-blind, randomized controlled trial. Curr Med Res Opin. 2014 Dec;30(12):2399-408. doi: 10.1185/03007995.2014.955169. Epub 2014 Sep 3.

    PubMed 25133963

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib 30 mg and Celecoxib 200 mg in people with Osteoarthritis of the Knee, run by Organon and Co.

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 15 inclusion and 28 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 Dec 2013). 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?

Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (time frame: Baseline, Week 2, Week 6, Week 12). 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 NCT01554163, which also lists 1 linked publication.

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 9 Feb 2022.

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