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Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The purpose of this study is to investigate whether naxozol protects the gastrointestinal tract effectively compared to celecoxib, a COX-2 inhibitor.
A total of 10 orthopedic investigators will participate in this study. The effectiveness in gastro-protection of study drug will be assessed by Leeds Dyspepsia Questionnaire (LDQ). The orthopedic investigators will be trained with this questionnaire administration by an expert gastroenterologist prior to starting this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Naproxen/Esomeprazol 500/20mg and Comparator-Placebo for 12 weeks |
|
| Comparator Group | Active Comparator | Celecoxib 200mg and Naxozol-Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen/Esomeprazol 500/20mg | Drug | Tablet, b.i.d. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Leads Dyspepsia Questionnaire (LDQ) Change | Mean change from baseline of Leads Dyspepsia Questionnaire | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean LDQ | Mean value of Leads Dyspepsia Questionnaire at 12 weeks | Baseline, 12 weeks |
| Gastrointestinal Symptom Rating Scale (GSRS) Change | Mean change from baseline of Gastrointestinal Symptom Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong-Hwan Moon, M.D., Ph.D. | Contact | 82 2 2228 5670 | shmoon@yuhs.ac | |
| Ji-Hye Kim | Contact | 82 2 2228 2824 | CORN@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Seong-Hwan Moon, M.D., Ph.D. | Severance Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Not yet recruiting | Anyang-si | South Korea |
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| Celecoxib 200mg | Drug | Capsule, o.d. |
|
|
| Naxozol-Placebo | Drug | Tablet (which is identical to Naxozol), b.i.d. |
|
| Comparator-Placebo | Drug | Capsule (which is identical to Celebrex), o.d. |
|
| Baseline, 12 weeks |
| Gastrointestinal Adverse Events Rate | Dyspepsia, Diarrhoea, Nausea, Abdominal Pain, Heartburn | Baseline, 12 weeks |
| Drug Discontinuation Rate Due to Gastrointestinal Adverse Events | Baseline, 12 weeks |
| Pain Relief Effect, mean change from baseline of Pain Visual Analogue Scale (VAS) | Mean change from baseline of Pain Visual Analogue Scale (VAS) | Baseline, 12 weeks |
| Quality of Life Change, mean change from baseline of EQ-5D | Mean change from baseline of EQ-5D | Baseline, 12 weeks |
| Treatment Compliance | Non-compliance is defined less than 80% | Baseline, 12 weeks |
| Rescue Drugs Usage | Acetaminophen ER 650mg and/or Almagate 500mg will be administrated for control of severe pain events and/or of severe gastrointestinal events. | Baseline, 12 weeks |
| Adverse Events | Adverse Events and Abnormalities from Vital Signs, Physical Exam, and Clinical Laboratories | Baseline, 12 weeks |
| Inje University Ilsan Paik Hospital | Not yet recruiting | Goyang-si | South Korea |
|
| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam-si | South Korea |
|
| Asan Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Ewha Womans University Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Gangnam Severance Hospital | Not yet recruiting | Seoul | South Korea |
|
| Hanyang University Seoul Hospital | Not yet recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Not yet recruiting | Seoul | South Korea |
|
| Seoul St. Mary's Hospital | Not yet recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D009853 | Omeprazole |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
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