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

NCT01554163 | Completed Phase 3 Results DMC

• 1 other identifier: 0663-112
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Celecoxib; Etoricoxib

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 2, Week 6, Week 12

Secondary Outcomes (6)

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

  Baseline, Week 2, Week 6, Week 12

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

  Baseline, Week 2, Week 6, Week 12

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

  Week 2, Week 6, Week 12

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

  Baseline, Week 2, Week 6, Week 12

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

  Baseline, Week 2, Week 6, Week 12

Study Arms (2)

Etoricoxib 30 mg

EXPERIMENTAL

Etoricoxib, 30 mg tablet, orally, once daily for 12 weeks.

Drug: Etoricoxib 30 mg

Celecoxib 200 mg

ACTIVE COMPARATOR

Celecoxib, 200 mg capsule, orally, once daily for 12 weeks.

Drug: Celecoxib 200 mg

Interventions

Etoricoxib 30 mg DRUG

Etoricoxib 30 mg tablet once daily for 12 weeks.

Also known as: MK-0663, Arcoxia

Etoricoxib 30 mg

Celecoxib 200 mg DRUG

Celecoxib 200 mg once daily for 12 weeks

Also known as: Celebrex, Celebra

Celecoxib 200 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• Patient has Class II-IV congestive heart failure
• Patient has established ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 25133963 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Etoricoxib; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazoles; Azoles

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 14, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 9, 2022
• Results First Posted: December 4, 2013

Record last verified: 2022-02