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This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol | Other | Treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Allopurinol | Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study. | Every month for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6. | Month 6 |
| Incidence of Gout Flares |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| S Baumgartner, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35242 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35835008 | Derived | Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29. | |
| 26190562 | Derived |
Not provided
Not provided
1,735 subjects enrolled in the study; however, only 1,732 were treated. Therefore, 1,732 subjects started the treatment period.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allopurinol | Treatment. Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Proportion of subjects who experienced at least one gout flare requiring treatment during the study. |
| Every month for 6 months. |
| Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10. | Month 6 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Bringham | Alabama | 35216 | United States |
| Calera | Alabama | 35040 | United States |
| Huntsville | Alabama | 35801 | United States |
| Mobile | Alabama | 36608 | United States |
| Chandlers | Arizona | 85224 | United States |
| Green Valley | Arizona | 85614 | United States |
| Jonesboro | Arizona | 72401 | United States |
| Phoenix | Arizona | 85028 | United States |
| Phoenix | Arizona | 85050 | United States |
| Tucson | Arizona | 85704 | United States |
| Little Rock | Arkansas | 72204 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Anaheim | California | 92805 | United States |
| Carmichael | California | 95608 | United States |
| Covina | California | 91723 | United States |
| Hemet | California | 92543 | United States |
| Irvine | California | 92618 | United States |
| Los Angeles | California | 90048 | United States |
| Mission Viejo | California | 92691 | United States |
| Pasadena | California | 91107 | United States |
| Sacramento | California | 95816 | United States |
| San Diego | California | 92108 | United States |
| San Ramon | California | 94583 | United States |
| Santa Maria | California | 93454 | United States |
| Weslake Village | California | 91361 | United States |
| Denver | Colorado | 80220 | United States |
| Englewood | Colorado | 80113 | United States |
| Danbury | Connecticut | 06810 | United States |
| Trumbull | Connecticut | 06611 | United States |
| Brandenton | Florida | 34208 | United States |
| Brandon | Florida | 33511 | United States |
| Brooksville | Florida | 34601 | United States |
| East Brandenton | Florida | 34208 | United States |
| Fleming Island | Florida | 32003 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jacksonville | Florida | 32216 | United States |
| Jupiter | Florida | 33458 | United States |
| Miami | Florida | 33135 | United States |
| Oldsmar | Florida | 34677 | United States |
| Orlando | Florida | 32804 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Plant City | Florida | 33563 | United States |
| Port Orange | Florida | 32127 | United States |
| Sanford | Florida | 32771 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Tampa | Florida | 33606 | United States |
| Vero Beach | Florida | 32960 | United States |
| Winter Haven | Florida | 33880 | United States |
| Zephyrhills | Florida | 33542 | United States |
| Atlanta | Georgia | 30308 | United States |
| Newnan | Georgia | 30265 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Meridian | Idaho | 83646 | United States |
| Addison | Illinois | 60101 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60637 | United States |
| Gurnee | Illinois | 60031 | United States |
| Evansville | Indiana | 47713 | United States |
| Elizabethtown | Kentucky | 42701 | United States |
| Lexington | Kentucky | 40504 | United States |
| Louisville | Kentucky | 40213 | United States |
| Monroe | Louisiana | 71203 | United States |
| Cumberland | Maryland | 21502 | United States |
| Frederick | Maryland | 21702 | United States |
| Hagerstown | Maryland | 21740 | United States |
| Wheaton | Maryland | 20902 | United States |
| Hyannis | Massachusetts | 02601 | United States |
| Worcester | Massachusetts | 01605 | United States |
| South Traverse City | Michigan | 49684 | United States |
| Rochester | Minnesota | 55905 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Florissant | Missouri | 63031 | United States |
| Kansas City | Missouri | 64114 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63128 | United States |
| Omaha | Nebraska | 68114 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Reno | Nevada | 89502 | United States |
| Nashua | New Hampshire | 03060 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Albany | New York | 12206 | United States |
| Endwell | New York | 13760 | United States |
| Hartsdale | New York | 10530 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Harrisburg | North Carolina | 28075 | United States |
| Hickory | North Carolina | 28602 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cleveland | Ohio | 44122 | United States |
| Columbus | Ohio | 43203 | United States |
| Dayton | Ohio | 45417 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Eugene | Oregon | 97402 | United States |
| Portland | Oregon | 97220 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Lancaster | Pennsylvania | 17601 | United States |
| Charleston | South Carolina | 29407 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Jackson | Tennessee | 38305 | United States |
| Spring Hill | Tennessee | 37174 | United States |
| Dallas | Texas | 75216 | United States |
| Dallas | Texas | 75235 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77088 | United States |
| Irving | Texas | 75061 | United States |
| Mesquite | Texas | 75150 | United States |
| San Antonio | Texas | 78229 | United States |
| Sugar Land | Texas | 77479 | United States |
| Bountiful | Utah | 84010 | United States |
| West Jordan | Utah | 84088 | United States |
| Arlington | Virginia | 22205 | United States |
| Richmond | Virginia | 23294 | United States |
| Port Orchard | Washington | 98366 | United States |
| Seattle | Washington | 98122 | United States |
| Spokane | Washington | 99208 | United States |
| Tacoma | Washington | 98405 | United States |
| Morgantown | West Virginia | 26505 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Wollongong | New South Wales | 2522 | Australia |
| Birsbane | Queensland | 4152 | Australia |
| Daw Park | South Australia | 5041 | Australia |
| Woodville South | South Australia | 5011 | Australia |
| Hobart | Tasmania | 7000 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Heidelberg | Victoria | 3081 | Australia |
| North Ballarat | Victoria | 3353 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Malvern East | VIC3145 | Australia |
| Brussels | 1070 | Belgium |
| Gozée | 6534 | Belgium |
| Kortrijk | 8500 | Belgium |
| Mouscron | 7700 | Belgium |
| Yvoir | 5530 | Belgium |
| Coquitlam | British Columbia | V3K 3P4 | Canada |
| Kelowna | British Columbia | V1Y 3G8 | Canada |
| Penticton | British Columbia | V2A 5C8 | Canada |
| Ottawa | Ontario | K1S 1L2 | Canada |
| Thornhill | Ontario | L4J 1W3 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Québec | Quebec | G1V 3M7 | Canada |
| Altenburg | 04600 | Germany |
| Dresden | 01307 | Germany |
| Eichstätt | 85072 | Germany |
| Christchurch | Canterbury | 8024 | New Zealand |
| Auckland | 1010 | New Zealand |
| Hamilton | 3240 | New Zealand |
| Papatoetoe | 2525 | New Zealand |
| Rotorua | 3010 | New Zealand |
| Tauranga | 3110 | New Zealand |
| Bloemfontein | 9301 | South Africa |
| Durban | 4037 | South Africa |
| Durban | 4067 | South Africa |
| Durban | 4092 | South Africa |
| East London | 5201 | South Africa |
| Johannesburg | 1724 | South Africa |
| Johannesburg | 2113 | South Africa |
| Paarl | 7646 | South Africa |
| Pretoria | 0084 | South Africa |
| Pretoria | 2000 | South Africa |
| Rondebosch | 7700 | South Africa |
| Stellenbosch | 7600 | South Africa |
| Thabazimbi | 0380 | South Africa |
| Worcester | 6850 | South Africa |
| Becker MA, Fitz-Patrick D, Choi HK, Dalbeth N, Storgard C, Cravets M, Baumgartner S. An open-label, 6-month study of allopurinol safety in gout: The LASSO study. Semin Arthritis Rheum. 2015 Oct;45(2):174-83. doi: 10.1016/j.semarthrit.2015.05.005. Epub 2015 May 21. |
| COMPLETED |
|
| NOT COMPLETED |
|
All subjects who received at least one dose of allopurinol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allopurinol | Treatment. Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at enrollment. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Allopurinol | Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study. | All subjects who received at least one dose of allopurinol | Posted | Number | percentage of subjects | Every month for 6 months. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6. | All subjects who received at least one dose of allopurinol | Posted | Number | 95% Confidence Interval | percentage of subjects | Month 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Incidence of Gout Flares | Proportion of subjects who experienced at least one gout flare requiring treatment during the study. | Subjects who received at least one dose of allopurinol | Posted | Number | 95% Confidence Interval | percentage of subjects | Every month for 6 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10. | Subjects who recieved at least one dose of allopurinol | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allopurinol | Treatment. Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label. | 52 | 1,732 | 654 | 1,732 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Death | General disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MeDRA 14.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MeDRA 14.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MeDRA 14.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pancreatic enzymes increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Breathing-related sleep disorder | Psychiatric disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Panic disorder with agoraphobia | Psychiatric disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MeDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Nasalphrayngitis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MeDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MeDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA 14.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MeDRA 14.0 | Non-systematic Assessment |
|
PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research and Development | Ardea Biosciences, Inc. | 858.652.6587 | sbaumgartner@ardeabio.com |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Belgium |
|
| Australia |
|
| South Africa |
|
| Germany |
|
| New Zealand |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|