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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoricoxib 30 mg | Experimental | Etoricoxib, 30 mg tablet, orally, once daily for 12 weeks. |
|
| Celecoxib 200 mg | Active Comparator | Celecoxib, 200 mg capsule, orally, once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib 30 mg | Drug | Etoricoxib 30 mg tablet once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
VAS)
Exclusion Criteria:
investigational drug or device within 4 weeks of signing informed consent
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25133963 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etoricoxib 30 mg | Etoricoxib 30 mg administered orally once daily for 12 weeks. |
| FG001 | Celecoxib 200 mg | Celecoxib 200 mg administered orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etoricoxib 30 mg | Etoricoxib 30 mg administered orally once daily for 12 weeks. |
| BG001 | Celecoxib 200 mg | Celecoxib 200 mg administered orally once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline, Week 2, Week 6, Week 12 |
|
Up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etoricoxib 30 mg | Etoricoxib 30 mg administered orally once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Celecoxib 200 mg | Drug | Celecoxib 200 mg once daily for 12 weeks |
|
|
| Baseline, Week 2, Week 6, Week 12 |
| 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. | Baseline, Week 2, Week 6, Week 12 |
| 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. | Week 2, Week 6, Week 12 |
| 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. | Baseline, Week 2, Week 6, Week 12 |
| 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. | Baseline, Week 2, Week 6, Week 12 |
| 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. | Week 6, Week 12 |
| Lost to Follow-up |
|
| Non-Compliance With Study Drug |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Not Treated |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Etoricoxib 30 mg | Etoricoxib 30 mg administered orally once daily for 12 weeks. |
| OG001 | Celecoxib 200 mg | Celecoxib 200 mg administered orally once daily for 12 weeks. |
|
|
|
| Secondary | 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. | The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
|
| Secondary | 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. | The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
|
| Secondary | 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. | The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Week 2, Week 6, Week 12 |
|
|
|
|
| Secondary | 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. | The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
|
| Secondary | 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. | The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
|
| Secondary | 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. | The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Week 6, Week 12 |
|
|
|
|
| 0 |
| 119 |
| 12 |
| 119 |
| EG001 | Celecoxib 200 mg | Celecoxib 200 mg administered orally once daily for 12 weeks. | 1 | 119 | 3 | 119 |
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011720 | Pyrazoles |
| D001393 | Azoles |