Trial · NCT02139046
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
NCT02139046, Phase 3, Completed, Takeda; results first posted 2016-11-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout. Trials, record NCT02139046. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02139046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
- NCT number
- NCT02139046
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,790 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat IR, Febuxostat XR, Febuxostat placebo, Colchicine, Naproxen, Lansoprazole
- First posted
- 2014-05-15
- Last updated
- 2016-11-03
- Results first posted
- 2016-11-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Month 3 | |
| Secondary | Percentage of Participants With at Least One Gout Flare Requiring Treatment | Baseline to Month 3 | A participant was considered to have a gout flare if the following criteria were met: Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare. |
| Secondary | Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3 | Month 3 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Month 3 | Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Gout Flare Requiring Treatment | Baseline to Month 3 | FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3 | Month 3 | FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Placebo | 0.3 | percentage of participants | ||
| Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Febuxostat IR 40 mg | 15.7 | percentage of participants | ||
| Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Febuxostat XR 40 mg | 25.9 | percentage of participants | ||
| Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Febuxostat IR 80 mg | 42.6 | percentage of participants | ||
| Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 | Febuxostat XR 80 mg | 50.1 | percentage of participants | ||
| Percentage of Participants With at Least One Gout Flare Requiring Treatment | Placebo | 20.7 | percentage of participants | ||
| Percentage of Participants With at Least One Gout Flare Requiring Treatment | Febuxostat IR 40 mg | 21.0 | percentage of participants | ||
| Percentage of Participants With at Least One Gout Flare Requiring Treatment | Febuxostat XR 40 mg | 22.8 | percentage of participants | ||
| Percentage of Participants With at Least One Gout Flare Requiring Treatment | Febuxostat IR 80 mg | 27.2 | percentage of participants | ||
| Percentage of Participants With at Least One Gout Flare Requiring Treatment | Febuxostat XR 80 mg | 26.6 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 358 | |
| Overall Study | STARTED | Febuxostat IR 40 mg | 359 | |
| Overall Study | STARTED | Febuxostat XR 40 mg | 357 | |
| Overall Study | STARTED | Febuxostat IR 80 mg | 358 | |
| Overall Study | STARTED | Febuxostat XR 80 mg | 358 | |
| Overall Study | Safety Analysis Set | Placebo | 356 | |
| Overall Study | Safety Analysis Set | Febuxostat IR 40 mg | 358 | |
| Overall Study | Safety Analysis Set | Febuxostat XR 40 mg | 355 | |
| Overall Study | Safety Analysis Set | Febuxostat IR 80 mg | 357 | |
| Overall Study | Safety Analysis Set | Febuxostat XR 80 mg | 357 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events265
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 13 | 356 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat IR 40 mg | 9 | 358 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat XR 40 mg | 9 | 355 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat IR 80 mg | 21 | 357 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat XR 80 mg | 9 | 357 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 11 | 356 | |
| other | Nasopharyngitis | Infections and infestations | Febuxostat IR 40 mg | 7 | 358 | |
| other | Nasopharyngitis | Infections and infestations | Febuxostat XR 40 mg | 7 | 355 | |
| other | Nasopharyngitis | Infections and infestations | Febuxostat IR 80 mg | 9 | 357 | |
| other | Nasopharyngitis | Infections and infestations | Febuxostat XR 80 mg | 4 | 357 |
1 to 10 of 265Source ClinicalTrials.gov
See all 265 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Febuxostat IR 40 mg | ||
| Total, all-cause mortality | Febuxostat XR 40 mg | ||
| Total, all-cause mortality | Febuxostat IR 80 mg | ||
| Total, all-cause mortality | Febuxostat XR 80 mg | ||
| Total, other adverse events | Placebo | 53 | 356 |
| Total, other adverse events | Febuxostat IR 40 mg | 53 | 358 |
| Total, other adverse events | Febuxostat XR 40 mg | 45 | 355 |
| Total, other adverse events | Febuxostat IR 80 mg | 55 | 357 |
| Total, other adverse events | Febuxostat XR 80 mg | 38 | 357 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30073793 | DERIVED |
Source PubMed
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/NCT02139046
GET https://conductscience.org/api/trials/v1/NCT02139046/flow?page=2