Trial · NCT01391325
Allopurinol Outcome Study
NCT01391325, Phase 4, Completed, Ardea Biosciences, Inc.; results first posted 2014-06-17
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Allopurinol Outcome Study. Trials, record NCT01391325. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01391325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allopurinol Outcome Study
- NCT number
- NCT01391325
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,735 participants, actual
- Lead sponsor
- Ardea Biosciences, Inc.
- Conditions
- Gout
- Interventions
- Allopurinol
- First posted
- 2011-07-12
- Last updated
- 2014-06-17
- Results first posted
- 2014-06-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Allopurinol | Every month for 6 months. | Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study. |
| Secondary | Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Month 6 | 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. |
| Secondary | Incidence of Gout Flares | Every month for 6 months. | Proportion of subjects who experienced at least one gout flare requiring treatment during the study. |
| Secondary | Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | Month 6 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of Allopurinol | Every month for 6 months. | All subjects who received at least one dose of allopurinol | percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Month 6 | All subjects who received at least one dose of allopurinol | percentage of subjects | NUMBER |
| SECONDARY | Incidence of Gout Flares | Every month for 6 months. | Subjects who received at least one dose of allopurinol | percentage of subjects | NUMBER |
| SECONDARY | Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | Month 6 | Subjects who recieved at least one dose of allopurinol | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Allopurinol | Allopurinol | 55.1 | percentage of subjects | ||
| Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Allopurinol | 43.4 | 95% Confidence Interval 41.0 to 46.0 | percentage of subjects | |
| Incidence of Gout Flares | Allopurinol | 33.4 | 95% Confidence Interval 31.0 to 36.0 | percentage of subjects | |
| Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | Allopurinol | SF-36 Physical Component Summary | 3.88 | Standard Deviation 8.458 | units on a scale |
| Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | Allopurinol | SF-36 Mental Health Component Summary | 0.71 | Standard Deviation 9.076 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allopurinol | 1,732 | |
| Overall Study | COMPLETED | Allopurinol | 1,238 | |
| Overall Study | NOT COMPLETED | Allopurinol | 494 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Tract Infection | Infections and infestations | Allopurinol | 100 | 1,732 | |
| other | Diarrhoea | Gastrointestinal disorders | Allopurinol | 77 | 1,732 | |
| other | Athralgia | Musculoskeletal and connective tissue disorders | Allopurinol | 55 | 1,732 | |
| other | Nasalphrayngitis | Infections and infestations | Allopurinol | 53 | 1,732 | |
| other | Blood creatine phosphokinase increased | Investigations | Allopurinol | 48 | 1,732 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Allopurinol | 45 | 1,732 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Allopurinol | 44 | 1,732 | |
| other | Hypertension | Vascular disorders | Allopurinol | 43 | 1,732 | |
| other | Headache | Nervous system disorders | Allopurinol | 41 | 1,732 | |
| other | Alanine aminotransferase increased | Investigations | Allopurinol | 38 | 1,732 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allopurinol | ||
| Total, other adverse events | Allopurinol | 654 | 1,732 |
| Total, serious adverse events | Allopurinol | 52 | 1,732 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01391325
GET https://conductscience.org/api/trials/v1/NCT01391325/events?page=2