Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
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ClinicalTrials.gov Identifier: NCT02139046 |
Recruitment Status :
Completed
First Posted : May 15, 2014
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Gout |
Interventions |
Drug: Febuxostat IR Drug: Febuxostat XR Drug: Febuxostat placebo Drug: Colchicine Drug: Naproxen Drug: Lansoprazole |
Enrollment | 1790 |
Participant Flow
Recruitment Details | Participants took part in the study at 217 investigative sites in the United States from 18 April 2014 to 18 November 2015. |
Pre-assignment Details | Participants with a diagnosis of gout were enrolled equally in 1 of 5 treatment groups: once a day placebo, febuxostat 40 mg extended release (XR), febuxostat 80 mg XR, febuxostat 40 mg immediate release (IR) or febuxostat 80 mg IR. |
Arm/Group Title | Placebo | Febuxostat IR 40 mg | Febuxostat XR 40 mg | Febuxostat IR 80 mg | Febuxostat XR 80 mg |
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Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
Period Title: Overall Study | |||||
Started | 358 | 359 | 357 | 358 | 358 |
Safety Analysis Set | 356 | 358 | 355 | 357 | 357 |
Full Analysis Set | 357 | 357 | 355 | 357 | 357 |
Completed | 296 [1] | 305 | 298 | 290 | 301 |
Not Completed | 62 | 54 | 59 | 68 | 57 |
Reason Not Completed | |||||
Pretreatment Event/Adverse Event | 9 | 9 | 10 | 13 | 7 |
Major Protocol Deviation | 9 | 10 | 16 | 12 | 6 |
Lost to Follow-up | 13 | 16 | 16 | 18 | 13 |
Voluntary Withdrawal | 20 | 8 | 10 | 15 | 16 |
Lack of Efficacy | 0 | 1 | 2 | 1 | 2 |
Withdrawal due to a Gout Flare | 1 | 1 | 1 | 0 | 1 |
Other Miscellaneous Reasons | 10 | 9 | 4 | 9 | 12 |
[1]
Completed=Completed Study Drug
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Baseline Characteristics
Arm/Group Title | Placebo | Febuxostat IR 40 mg | Febuxostat XR 40 mg | Febuxostat IR 80 mg | Febuxostat XR 80 mg | Total | |
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Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. | Total of all reporting groups | |
Overall Number of Baseline Participants | 357 | 357 | 355 | 357 | 357 | 1783 | |
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Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants | |
54.4 (11.55) | 55.5 (11.07) | 55.1 (12.68) | 54.9 (11.32) | 55.4 (11.93) | 55.1 (11.71) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
< 45 years | 71 | 58 | 74 | 68 | 61 | 332 | |
45 to < 65 years | 223 | 225 | 193 | 219 | 222 | 1082 | |
>= 65 years | 63 | 74 | 88 | 70 | 74 | 369 | |
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
18 to < 65 years | 294 | 283 | 267 | 287 | 283 | 1414 | |
65 to < 85 years | 60 | 73 | 86 | 69 | 73 | 361 | |
>= 85 years | 3 | 1 | 2 | 1 | 1 | 8 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants | |
Female |
41 11.5%
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46 12.9%
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43 12.1%
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42 11.8%
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34 9.5%
|
206 11.6%
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Male |
316 88.5%
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311 87.1%
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312 87.9%
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315 88.2%
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323 90.5%
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1577 88.4%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
American Indian or Alaska Native | 1 | 2 | 0 | 1 | 3 | 7 | |
Asian | 23 | 19 | 22 | 23 | 25 | 112 | |
Black or African American | 94 | 89 | 100 | 98 | 93 | 474 | |
Native Hawaiian or Other Pacific Islander | 3 | 5 | 4 | 3 | 5 | 20 | |
White | 231 | 235 | 226 | 230 | 225 | 1147 | |
Other: Multi-Racial | 5 | 7 | 3 | 2 | 6 | 23 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
Hispanic or Latino | 53 | 51 | 61 | 49 | 52 | 266 | |
Not Hispanic or Latino | 304 | 306 | 294 | 308 | 305 | 1517 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
357 | 357 | 355 | 357 | 357 | 1783 | ||
Height
[1] Mean (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants | |
175.2 (9.95) | 174.8 (10.46) | 174.4 (10.45) | 174.3 (9.42) | 175.3 (9.50) | 174.8 (9.96) | ||
[1]
Measure Description: Height data is only available for 356, 357, 355, 357 and 357 participants, respectively.
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants | |
106.83 (25.285) | 104.65 (24.157) | 104.71 (27.995) | 102.16 (22.832) | 104.64 (23.033) | 104.60 (24.745) | ||
Body Mass Index (BMI)
[1] Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants | |
34.88 (8.276) | 34.32 (8.014) | 34.29 (8.141) | 33.68 (7.477) | 34.08 (7.205) | 34.25 (7.834) | ||
[1]
Measure Description: BMI data is only available for 356, 357, 355, 357 and 357 participants, respectively.
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Smoking History
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
Never Smoked | 191 | 190 | 185 | 190 | 205 | 961 | |
Current Smoker | 58 | 56 | 60 | 65 | 47 | 286 | |
Ex-Smoker | 108 | 111 | 110 | 102 | 105 | 536 | |
Alcohol Classification
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 357 participants | 357 participants | 355 participants | 357 participants | 357 participants | 1783 participants |
Never Drank | 81 | 92 | 85 | 68 | 74 | 400 | |
Current Drinker | 234 | 204 | 218 | 234 | 232 | 1122 | |
Ex-Drinker | 42 | 61 | 52 | 55 | 51 | 261 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Takeda |
Phone: | +1-877-825-3327 |
EMail: | trialdisclosures@takeda.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT02139046 |
Other Study ID Numbers: |
FEB-XR_301 U1111-1152-4040 ( Other Identifier: World Health Organization ) |
First Submitted: | May 13, 2014 |
First Posted: | May 15, 2014 |
Results First Submitted: | September 15, 2016 |
Results First Posted: | November 3, 2016 |
Last Update Posted: | November 3, 2016 |