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The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam Test Capsules | Experimental | One Capsule QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Test Capsules | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died. | Baseline to Week 52/Early Termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Meloxicam 10 mg | Participants were administered Meloxicam 10 mg once daily for up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85053 |
| United States |
| Carmichael | California | 95608 | United States |
| Pismo Beach | California | 93449 | United States |
| Milford | Connecticut | 06460 | United States |
| DeLand | Florida | 32720 | United States |
| Fleming Island | Florida | 32003 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jacksonville | Florida | 32216 | United States |
| Miami | Florida | 33143 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Ponte Vedra | Florida | 32081 | United States |
| Newton | Kansas | 67114 | United States |
| Prairie Village | Kansas | 66206 | United States |
| Wichita | Kansas | 67203 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Brockton | Massachusetts | 02301 | United States |
| Traverse City | Michigan | 49684 | United States |
| Troy | Michigan | 48098 | United States |
| Hazelwood | Missouri | 63042 | United States |
| St Louis | Missouri | 63141 | United States |
| Omaha | Nebraska | 68134 | United States |
| Las Vegas | Nevada | 89144 | United States |
| Hartsdale | New York | 10530 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cincinnati | Ohio | 45255 | United States |
| Cincinnati | Ohio | 45256 | United States |
| Columbus | Ohio | 43212 | United States |
| Kettering | Ohio | 45429 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Anderson | South Carolina | 29621 | United States |
| Clinton | South Carolina | 29325 | United States |
| Austin | Texas | 78705 | United States |
| Plano | Texas | 75075 | United States |
| San Antonio | Texas | 78209 | United States |
| San Antonio | Texas | 78229 | United States |
| Charlottesville | Virginia | 22911 | United States |
| Roanoke | Virginia | 24018 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Meloxicam 10 mg | Participants were administered Meloxicam 10 mg once daily for up to 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times. | Number | participants |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died. | Posted | Number | participants | Baseline to Week 52/Early Termination |
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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 | Meloxicam 10 mg | Participants were administered Meloxicam 10 mg once daily for up to 52 weeks. | 35 | 600 | 65 | 600 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| Angina pectoris | Cardiac disorders |
| |||
| Cardiac failure acute | Cardiac disorders |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Coronary artery stenosis | Cardiac disorders |
| |||
| Diverticulum intestinal hemorrhagic | Gastrointestinal disorders |
| |||
| Duodenal ulcer hemorrhage | Gastrointestinal disorders |
| |||
| Gastric ulcer hemorrhage | Gastrointestinal disorders |
| |||
| Gastroesophageal reflux disease | Gastrointestinal disorders |
| |||
| Chest pain | General disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Drug-induced liver injury | Hepatobiliary disorders |
| |||
| Appendicitis perforated | Infections and infestations |
| |||
| Bronchitis | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Lobar pneumonia | Infections and infestations |
| |||
| Meningitis bacterial | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Staphylococcal sepsis | Infections and infestations |
| |||
| Post procedural complication | Injury, poisoning and procedural complications |
| |||
| Road traffic accident | Injury, poisoning and procedural complications |
| |||
| Spinal compression fracture | Injury, poisoning and procedural complications |
| |||
| Costochondritis | Musculoskeletal and connective tissue disorders |
| |||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Lung squamous cell carcinoma, stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Carotid artery stenosis | Nervous system disorders |
| |||
| Hemorrhagic cerebral infarction | Nervous system disorders |
| |||
| Fourth nerve paralysis | Nervous system disorders |
| |||
| Renal failure acute | Renal and urinary disorders |
| |||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Medical device removal | Surgical and medical procedures |
| |||
| Aortic aneurysm rupture | Vascular disorders |
| |||
| Hypertensive crisis | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Urinary tract infection | Infections and infestations |
|
Investigator is required to submit any materials describing the results of the study at the site to sponsor for review not less than 30 days prior to publication and agrees to remove any of the Sponsor's confidential information. Sponsor also retains right to delay publication for an additional 60 day period to allow time for filing of patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis Gomez, Director of Clinical Operations | Iroko Pharmaceuticals, LLC | 267-546-1426 | agomez@iroko.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Unknown or Not Reported |
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| Black or African-American |
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| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Title | Measurements |
|---|---|
|
| Subjects with at least 1 treatment-related TEAE |
|
| Subjects with AEs leading to discontinuation |
|
| Subjects who died |
|