Trial Outcomes & Findings for Allopurinol Outcome Study (NCT NCT01391325)
NCT ID: NCT01391325
Last Updated: 2014-06-17
Results Overview
Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1735 participants
Primary outcome timeframe
Every month for 6 months.
Results posted on
2014-06-17
Participant Flow
1,735 subjects enrolled in the study; however, only 1,732 were treated. Therefore, 1,732 subjects started the treatment period.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1732
|
|
Overall Study
COMPLETED
|
1238
|
|
Overall Study
NOT COMPLETED
|
494
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allopurinol Outcome Study
Baseline characteristics by cohort
| Measure |
Allopurinol
n=1732 Participants
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1483 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
249 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1614 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1203 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
74 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
104 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
242 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every month for 6 months.Population: All subjects who received at least one dose of allopurinol
Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.
Outcome measures
| Measure |
Allopurinol
n=1732 Participants
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Safety of Allopurinol
|
55.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 6Population: All subjects who received at least one dose of allopurinol
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.
Outcome measures
| Measure |
Allopurinol
n=1732 Participants
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL
|
43.4 percentage of subjects
Interval 41.0 to 46.0
|
SECONDARY outcome
Timeframe: Every month for 6 months.Population: Subjects who received at least one dose of allopurinol
Proportion of subjects who experienced at least one gout flare requiring treatment during the study.
Outcome measures
| Measure |
Allopurinol
n=1732 Participants
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Incidence of Gout Flares
|
33.4 percentage of subjects
Interval 31.0 to 36.0
|
SECONDARY outcome
Timeframe: Month 6Population: Subjects who recieved at least one dose of allopurinol
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.
Outcome measures
| Measure |
Allopurinol
n=1732 Participants
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Mean Change From Baseline to Month 6 in SF-36 PCS+MCS
SF-36 Physical Component Summary
|
3.88 units on a scale
Standard Deviation 8.458
|
|
Mean Change From Baseline to Month 6 in SF-36 PCS+MCS
SF-36 Mental Health Component Summary
|
0.71 units on a scale
Standard Deviation 9.076
|
Adverse Events
Allopurinol
Serious events: 52 serious events
Other events: 654 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allopurinol
n=1732 participants at risk
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
3/1732 • Number of events 3 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Cardiac disorders
Atrial flutter
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericarditis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericarditis constrictive
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
General disorders
Death
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
General disorders
Sudden death
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Abscess
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Abscess intestinal
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Abscess limb
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Infections and infestations
Cholecystitis infective
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Diverticulitis
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Meningitis viral
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Osteomyelitis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Perirectal abscess
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.17%
3/1732 • Number of events 3 • 6 months
|
|
Infections and infestations
Sepsis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Staphylococcal infection
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Investigations
Blood glucose increased
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Investigations
Blood pressure increased
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Investigations
Pancreatic enzymes increased
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Gout
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
2/1732 • Number of events 2 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Nervous system disorders
Convulsion
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Bipolar I disorder
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Breathing-related sleep disorder
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Panic disorder with agoraphobia
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1732 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
|
Vascular disorders
Thrombosis
|
0.06%
1/1732 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Allopurinol
n=1732 participants at risk
Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
|
|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
100/1732 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
77/1732 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
3.2%
55/1732 • 6 months
|
|
Infections and infestations
Nasalphrayngitis
|
3.1%
53/1732 • 6 months
|
|
Investigations
Blood creatine phosphokinase increased
|
2.8%
48/1732 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
45/1732 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
44/1732 • 6 months
|
|
Vascular disorders
Hypertension
|
2.5%
43/1732 • 6 months
|
|
Nervous system disorders
Headache
|
2.4%
41/1732 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
38/1732 • 6 months
|
|
Infections and infestations
Bronchitis
|
1.7%
29/1732 • 6 months
|
|
Infections and infestations
Influenza
|
1.5%
26/1732 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
26/1732 • 6 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.4%
25/1732 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
24/1732 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
23/1732 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
22/1732 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
20/1732 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
1.1%
19/1732 • 6 months
|
|
Investigations
Liver function test abnormal
|
1.1%
19/1732 • 6 months
|
Additional Information
Vice President, Clinical Research and Development
Ardea Biosciences, Inc.
Phone: 858.652.6587
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER