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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-2275 | Registry Identifier | WHO |
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The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole 30 mg QD + Naproxen 500 mg BID | Experimental | (and added aspirin) |
|
| Celecoxib 200 mg QD | Active Comparator | (and added aspirin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole and naproxen and aspirin | Drug | Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroduodenal ulcers at final visit | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) | Week 12 | |
| Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. | Weeks 4,8, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17916545 | Result | Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. doi: 10.1016/j.cgh.2007.06.009. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010437 | Peptic Ulcer |
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D009288 | Naproxen |
| D001241 | Aspirin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Celecoxib and aspirin | Drug | Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. |
|
| Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. | Weeks 4,8, and 12 |
| Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. | Weeks 4, 8, and 12 |
| Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. | Weeks 4, 8, and 12 |
| The change from baseline SODA scale for subjects with dyspepsia at baseline. | Weeks 4, 8, and 12 |
| D004378 |
| Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D011720 | Pyrazoles |
| D001393 | Azoles |