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| Name | Class |
|---|---|
| EPIC Research CRO | INDUSTRY |
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The goal of this clinical trial is to learn if fixed-dose combination etoricoxib 90 mg + diacerein 50 mg capsule works to treat knee/hip osteoarthritis-associated pain in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does etoricoxib+diacerein reduce pain intensity as per WOMAC scale after 60 days? What medical problems do participants have when taking etoricoxib 90 mg+diacerein 50 mg capsule for 60 days? Researchers will compare the test drug etoricoxib 90 mg+diacerein 50 mg capsule to an active comparator (meloxicam 15 mg + diacereina 50 mg) to see if drug ABC works to treat pain in patients with osteoarthritis.
Participants will:
Take drug the test or comparator drugs every day for 60 days. Visit the clinic once a month for health and outcomes follow-up. Keep a diary of their symptoms, pain intensity, WOMAC scale, adverse events, rescue medication use, other used drugs, and treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoricoxib 90 mg + diacerein 50 mg | Experimental | One capsule |
|
| Meloxicam 15 mg + diacerein 50 mg | Active Comparator | One capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib 90 mg + diacerein 50 mg | Drug | Once a day for 60 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity change | Pain intensity change measured by 100 mm - Visual Analogue Scale. A reduction of 20 mm or higher means a clinically relevant outcome. | At 60 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarthritis index change | Western Ontario and McMaster Universities Arthritis Index (WOMAC)
| At 60 days from baseline |
| Use of rescue medication |
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Inclusion Criteria:
Adult men and women (≥ 18 and ≤ 65 years of age).
Patients who agree to participate in the study by signing the informed consent form.
Patients with a clinical diagnosis of knee or hip OA according to the American College of Rheumatology criteria with radiographic evidence of OA (K-L score ≥2) in the index joint (defined as the joint with OA being evaluated in this study).
Patients with moderate to severe pain in the index joint defined as a WOMAC pain subscore of ≥4.
Patients who, in the investigator's medical judgment, can discontinue current analgesic medications and are willing to comply with the study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Livan Delgado Roche, Ph.D. | Laboratorios Liomont | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo Médico ASSET, S.C. | Mexico City | Mexico City | 03100 | Mexico | ||
| RM Pharma Specialists S.A. de C.V. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25889669 | Background | Kongtharvonskul J, Anothaisintawee T, McEvoy M, Attia J, Woratanarat P, Thakkinstian A. Efficacy and safety of glucosamine, diacerein, and NSAIDs in osteoarthritis knee: a systematic review and network meta-analysis. Eur J Med Res. 2015 Mar 13;20(1):24. doi: 10.1186/s40001-015-0115-7. | |
| 30863143 | Background |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| C025292 | diacerein |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Meloxicam 15 mg + diacerein 50 mg |
| Drug |
Once a day for 60 days. |
|
Proportion of patients need to use rescue medication. |
| At 60 days from baseline. |
| Quality of Life | Quality of Life will be measured using the Short Form-12 Health Survey (SF-12). SF-12 health survey, which yields two norm-based summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each score is standardized to a general population mean of 50 (SD = 10), where higher scores indicate better health-related quality of life." | At 60 days from baseline. |
| Safety and tolerability | Proportion of patients experienced at least one adverse event. | At 60 days from informed consent sign. |
| Mexico City |
| Mexico City |
| 03100 |
| Mexico |
| Ainpad, S.C. | Morelia | Michoacán | 58350 | Mexico |
| Hospital Centro Quirúrgico Nogalar, S.A. de C.V. | Monterrey | Nuevo León | 66484 | Mexico |
| Cuomo A, Bimonte S, Forte CA, Botti G, Cascella M. Multimodal approaches and tailored therapies for pain management: the trolley analgesic model. J Pain Res. 2019 Feb 19;12:711-714. doi: 10.2147/JPR.S178910. eCollection 2019. |
| 22870441 | Background | Martel-Pelletier J, Pelletier JP. Effects of diacerein at the molecular level in the osteoarthritis disease process. Ther Adv Musculoskelet Dis. 2010 Apr;2(2):95-104. doi: 10.1177/1759720X09359104. |
| 29309269 | Background | Lespasio MJ, Sultan AA, Piuzzi NS, Khlopas A, Husni ME, Muschler GF, Mont MA. Hip Osteoarthritis: A Primer. Perm J. 2018;22:17-084. doi: 10.7812/TPP/17-084. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013843 | Thiazines |
| D013844 | Thiazoles |
| D001393 | Azoles |