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Trial record 1 of 1 for:    TMX-67_204
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Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout

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ClinicalTrials.gov Identifier: NCT01078389
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Joint Damage
Interventions Drug: Febuxostat
Drug: Placebo for Febuxostat
Enrollment 314

Recruitment Details Participants took part in the study at 65 investigative sites in the United States from 10 March 2010 to 3 September 2013.
Pre-assignment Details Participants with a diagnosis of gout were enrolled equally in 1 of 2 treatment groups, once a day placebo or febuxostat 40 mg or 80 mg based on serum urate levels.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months. Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Period Title: Overall Study
Started 157 157
Completed 93 90
Not Completed 64 67
Reason Not Completed
Adverse Event             10             6
Major Protocol Deviation             2             0
Lost to Follow-up             23             23
Voluntary Withdrawal             20             36
Other             9             2
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo Total
Hide Arm/Group Description Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months. Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months. Total of all reporting groups
Overall Number of Baseline Participants 157 157 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 157 participants 314 participants
51.4  (12.36) 50.1  (11.72) 50.8  (12.04)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
<45 years 49 42 91
45 to <65 years 85 99 184
≥65 years 23 16 39
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
Female
14
   8.9%
12
   7.6%
26
   8.3%
Male
143
  91.1%
145
  92.4%
288
  91.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
American Indian or Alaska Native 1 0 1
Asian 8 10 18
Black or African American 25 24 49
Native Hawaiian or Other Pacific Islander 1 0 1
White 119 121 240
Other 3 2 5
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
Hispanic or Latino 26 36 62
Not Hispanic or Latino 131 121 252
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 157 participants 157 participants 314 participants
157 157 314
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 157 participants 157 participants 314 participants
176.3  (9.22) 176.5  (8.36) 176.4  (8.79)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 157 participants 157 participants 314 participants
102.8  (20.88) 100.7  (21.20) 101.7  (21.04)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 157 participants 157 participants 314 participants
33.1  (6.40) 32.3  (6.23) 32.7  (6.32)
BMI Categories  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
<25 kg/m^2 11 11 22
25 to <30 kg/m^2 37 46 83
≥30 kg/m^2 109 100 209
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
Never Smoked 84 94 178
Current Smoker 32 25 57
Ex-Smoker 41 38 79
Alcohol History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
Never Drank 37 35 72
Current Drinker 103 106 209
Ex-Drinker 17 16 33
Renal History (Modification of Diet in Renal Disease [MDRD])  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 314 participants
Moderately Impaired MDRD 3 2 5
Mildly Impaired MDRD 105 115 220
Normal MDRD 49 40 89
1.Primary Outcome
Title Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint
Hide Description The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.
Time Frame Baseline and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.16  (0.444) 0.11  (0.438)
Change from Baseline at Month 24 0.01  (0.330) 0.01  (0.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments [Not Specified]
Method Ranked Analysis of Covariance (ANCOVA)
Comments Baseline modified Sharp/van der Heijde Erosion Score as a covariate.
2.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs
Hide Description Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.
Time Frame Baseline and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Number of Participants Analyzed 91 86
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.98  (9.707) 4.56  (8.631)
Change from Baseline at Month 24 (n=78,74) 0.31  (2.447) 0.29  (1.746)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.548
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.
3.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs
Hide Description Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.
Time Frame Baseline and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Number of Participants Analyzed 91 86
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.36  (1.160) 0.17  (0.473)
Change from Baseline at Month 24 (n=78,74) 0.17  (1.709) 0.11  (0.969)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.
4.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint
Hide Description The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.
Time Frame Baseline and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Number of Participants Analyzed 157 157
Mean (Standard Deviation)
Unit of Measure: score on a scale
Synovitis:Baseline (BL)(n=82,76) 1.29  (0.782) 1.09  (0.687)
Synovitis:Change from Baseline (n=75,67) -0.43  (0.713) -0.07  (0.531)
Erosion (Distal+Proximal):Baseline (n=84,77) 1.63  (0.935) 1.48  (0.916)
Erosion (Distal+Proximal):Change from BL(n=79,69) -0.01  (0.702) 0.04  (0.475)
Edema (Distal+Proximal):Baseline (BL) (n=81,75) 0.73  (1.022) 0.51  (0.919)
Edema (Distal+Proximal):Change from BL(n=77,66) -0.36  (0.916) -0.10  (0.962)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Synovitis: Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline RAMRIS Synovitis Score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Erosion(Distal+Proximal): Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Edema(Distal+Proximal): Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.
5.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint
Hide Description The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.
Time Frame Baseline and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.85  (1.057) 0.77  (1.022)
Change from Baseline at Month 24(n=81,76) 0.00  (0.602) 0.05  (0.361)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg or 80 mg, Placebo
Comments Change from Baseline at Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method Ranked ANCOVA
Comments Baseline modified Sharp/van der Heijde Total Score as a covariate.
Time Frame Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Febuxostat 40 mg or 80 mg Placebo
Hide Arm/Group Description Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months. Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
All-Cause Mortality
Febuxostat 40 mg or 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg or 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/157 (8.28%)   11/157 (7.01%) 
Cardiac disorders     
Cardiac failure congestive  1 [1]  1/157 (0.64%)  1/157 (0.64%) 
Acute myocardial infarction  1  1/157 (0.64%)  0/157 (0.00%) 
Angina pectoris  1  1/157 (0.64%)  0/157 (0.00%) 
Mitral valve incompetence  1  0/157 (0.00%)  1/157 (0.64%) 
Left ventricular dysfunction  1  0/157 (0.00%)  1/157 (0.64%) 
Atrial fibrillation  1  0/157 (0.00%)  1/157 (0.64%) 
Ventricular fibrillation  1 [2]  0/157 (0.00%)  1/157 (0.64%) 
Eye disorders     
Vitreous haemorrhage  1  0/157 (0.00%)  1/157 (0.64%) 
Diabetic retinopathy  1  0/157 (0.00%)  1/157 (0.64%) 
Gastrointestinal disorders     
Colitis  1  1/157 (0.64%)  0/157 (0.00%) 
General disorders     
Impaired healing  1  0/157 (0.00%)  1/157 (0.64%) 
Oedema peripheral  1  1/157 (0.64%)  0/157 (0.00%) 
Chest pain  1  0/157 (0.00%)  1/157 (0.64%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/157 (0.64%)  0/157 (0.00%) 
Cholelithiasis  1  1/157 (0.64%)  0/157 (0.00%) 
Bile duct obstruction  1  1/157 (0.64%)  0/157 (0.00%) 
Infections and infestations     
Appendicitis  1  1/157 (0.64%)  0/157 (0.00%) 
Cellulitis  1  0/157 (0.00%)  1/157 (0.64%) 
Bursitis infective  1  1/157 (0.64%)  0/157 (0.00%) 
Osteomyelitis  1  0/157 (0.00%)  1/157 (0.64%) 
Hepatic infection  1  0/157 (0.00%)  1/157 (0.64%) 
Incision site infection  1  0/157 (0.00%)  1/157 (0.64%) 
Pneumonia  1  1/157 (0.64%)  0/157 (0.00%) 
Chest wall abscess  1  1/157 (0.64%)  0/157 (0.00%) 
Sepsis  1  1/157 (0.64%)  0/157 (0.00%) 
Pneumonia streptococcal  1  1/157 (0.64%)  0/157 (0.00%) 
Metabolism and nutrition disorders     
Gout  1  0/157 (0.00%)  1/157 (0.64%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/157 (0.00%)  1/157 (0.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma of lung  1  1/157 (0.64%)  0/157 (0.00%) 
Malignant melanoma  1  1/157 (0.64%)  0/157 (0.00%) 
Uterine leiomyoma  1  1/157 (0.64%)  0/157 (0.00%) 
Nervous system disorders     
Dizziness  1  0/157 (0.00%)  1/157 (0.64%) 
Renal and urinary disorders     
Nephropathy  1  1/157 (0.64%)  0/157 (0.00%) 
Oliguria  1  1/157 (0.64%)  0/157 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/157 (0.00%)  2/157 (1.27%) 
Chronic obstructive pulmonary disease  1  1/157 (0.64%)  0/157 (0.00%) 
Acute respiratory failure  1  1/157 (0.64%)  0/157 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/157 (0.00%)  1/157 (0.64%) 
Vascular disorders     
Arteriosclerosis  1  0/157 (0.00%)  1/157 (0.64%) 
Peripheral vascular disorder  1  1/157 (0.64%)  0/157 (0.00%) 
Peripheral arterial occlusive disease  1  1/157 (0.64%)  0/157 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
[1]
One treatment-emergent death occurred during treatment with febuxostat and is not related.
[2]
One treatment-emergent death occurred during treatment with placebo and is not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Febuxostat 40 mg or 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   73/157 (46.50%)   67/157 (42.68%) 
Gastrointestinal disorders     
Diarrhoea  1  9/157 (5.73%)  6/157 (3.82%) 
General disorders     
Oedema peripheral  1  8/157 (5.10%)  5/157 (3.18%) 
Infections and infestations     
Upper respiratory tract infection  1  15/157 (9.55%)  16/157 (10.19%) 
Investigations     
Aspartate aminotransferase increased  1  11/157 (7.01%)  6/157 (3.82%) 
Blood creatine phosphokinase increased  1  9/157 (5.73%)  11/157 (7.01%) 
Alanine aminotransferase increased  1  10/157 (6.37%)  6/157 (3.82%) 
Gamma-glutamyltransferase increased  1  6/157 (3.82%)  9/157 (5.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  14/157 (8.92%)  10/157 (6.37%) 
Pain in extremity  1  9/157 (5.73%)  13/157 (8.28%) 
Back pain  1  9/157 (5.73%)  6/157 (3.82%) 
Musculoskeletal pain  1  4/157 (2.55%)  8/157 (5.10%) 
Nervous system disorders     
Headache  1  5/157 (3.18%)  10/157 (6.37%) 
Vascular disorders     
Hypertension  1  8/157 (5.10%)  7/157 (4.46%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
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, Clinical Science
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01078389     History of Changes
Other Study ID Numbers: TMX-67_204
U1111-1113-8098 ( Registry Identifier: WHO )
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: September 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014