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Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01355081
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : November 11, 2014
Last Update Posted : November 11, 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 Major Depressive Disorder
Interventions Drug: Vortioxetine
Drug: Placebo
Enrollment 366
Recruitment Details Participants took part in the study at 32 investigative sites throughout Japan from 13 May 2011 to 21 December 2012.
Pre-assignment Details Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups: once a day 5 mg or 10 mg vortioxetine (Lu AA21004) or placebo.
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Period Title: Overall Study
Started 119 123 124
Completed 112 113 113
Not Completed 7 10 11
Reason Not Completed
Pretreatment Event or Adverse Event             3             4             6
Major Protocol Deviation             0             1             0
Lost to Follow-up             0             0             1
Withdrawal of Consent             2             3             3
Lack of Efficacy             2             1             1
Non Compliance with Study Medication             0             1             0
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo Total
Hide Arm/Group Description Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 119 123 124 366
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 123 participants 124 participants 366 participants
38.8  (10.85) 38.8  (10.99) 37.6  (10.67) 38.4  (10.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Female
50
  42.0%
54
  43.9%
67
  54.0%
171
  46.7%
Male
69
  58.0%
69
  56.1%
57
  46.0%
195
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 119 participants 123 participants 124 participants 366 participants
119 123 124 366
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 119 participants 123 participants 124 participants 366 participants
165.7  (8.45) 165.6  (8.51) 163.9  (8.46) 165.1  (8.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 119 participants 123 participants 124 participants 366 participants
62.18  (11.357) 62.11  (15.883) 60.86  (12.690) 61.71  (13.441)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 119 participants 123 participants 124 participants 366 participants
22.59  (3.366) 22.42  (4.306) 22.57  (4.016) 22.53  (3.911)
Cytochrome p450 (CYP)2D6 Phenotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Ultra-rapid Metabolizer (UM) 1 1 2 4
Extensive Metabolizer (EM) 91 97 96 284
Intermediate Metabolizer (IM) 25 20 21 66
Poor Metabolizer (PM) 0 1 0 1
Unknown 2 4 5 11
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Current smoker 39 41 40 120
Ex-smoker 26 24 24 74
Never Smoked 54 58 60 172
History of Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Never 34 32 41 107
Once Monthly or Less Often 33 40 40 113
Once a Week 16 20 20 56
2 to 6 Times/Week 21 20 15 56
Daily 15 11 8 34
Status of Major Depressive Episode (MDE)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Single episode 70 68 76 214
Recurrent episode 49 55 48 152
[1]
Measure Description: An MDE is a period marked by depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.
Pharmacotherapy for Current Major Depressive Episode  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 123 participants 124 participants 366 participants
Yes 68 68 74 210
No 51 55 50 156
Montgomery Åsberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 119 participants 123 participants 124 participants 366 participants
32.2  (4.81) 32.5  (4.93) 32.5  (4.50) 32.4  (4.74)
[1]
Measure Description: The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression).
Hamilton Depression Scale (HAM-D17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 119 participants 123 participants 124 participants 366 participants
20.9  (4.12) 21.2  (4.43) 21.5  (4.48) 21.2  (4.34)
[1]
Measure Description: The HAM-D17 is a clinician-rated scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 where a higher score indicates a greater depressive state.
Clinical Global Impression - Severity Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 119 participants 123 participants 124 participants 366 participants
4.5  (0.65) 4.5  (0.64) 4.6  (0.69) 4.5  (0.66)
[1]
Measure Description: The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Sheehan Disability Scale (SDS) - Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 119 participants 123 participants 124 participants 366 participants
15.5  (6.12) 15.2  (5.97) 15.4  (5.45) 15.4  (5.83)
[1]
Measure Description: The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
1.Primary Outcome
Title Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
Hide Description MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 122 123
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-15.84  (0.885) -14.85  (0.874) -13.81  (0.870)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vortioxetine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1031
Comments [Not Specified]
Method ANCOVA
Comments Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Method of Estimation Estimation Parameter Least square means difference
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-4.467 to 0.413
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.241
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vortioxetine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4008
Comments [Not Specified]
Method ANCOVA
Comments Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-3.461 to 1.387
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.233
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients With MADRS Response After 8 Weeks of Treatment
Hide Description MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 122 123
Measure Type: Number
Unit of Measure: percentage of participants
51.3 45.9 39.8
3.Secondary Outcome
Title Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
Hide Description MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 122 123
Measure Type: Number
Unit of Measure: percentage of participants
29.4 28.7 22.0
4.Secondary Outcome
Title Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
Hide Description The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward.
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 121 122
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-9.56  (0.586) -8.54  (0.580) -8.40  (0.578)
5.Secondary Outcome
Title Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
Hide Description The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 122 123
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.44  (0.100) 2.57  (0.099) 2.66  (0.099)
6.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
Hide Description The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description:
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 119 121 122
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-5.01  (0.510) -4.02  (0.506) -2.91  (0.504)
Time Frame 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks)
Adverse Event Reporting Description At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
 
Arm/Group Title Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Hide Arm/Group Description Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks. Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
All-Cause Mortality
Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/119 (0.84%)   1/122 (0.82%)   1/124 (0.81%) 
Injury, poisoning and procedural complications       
Brain contusion  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Road traffic accident  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer recurrent  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Nervous system disorders       
Cerebral haematoma  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Subarachnoid haemorrhage  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Psychiatric disorders       
Suicidal behaviour  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vortioxetine 5 mg Vortioxetine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   80/119 (67.23%)   93/122 (76.23%)   78/124 (62.90%) 
Cardiac disorders       
Tachycardia  1  0/119 (0.00%)  1/122 (0.82%)  1/124 (0.81%) 
Palpitations  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Ventricular extrasystoles  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  3/119 (2.52%)  1/122 (0.82%)  0/124 (0.00%) 
Tinnitus  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Motion sickness  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Eye disorders       
Asthenopia  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Blepharospasm  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Conjunctivitis  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Ocular hypertension  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Visual impairment  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Gastrointestinal disorders       
Nausea  1  20/119 (16.81%)  35/122 (28.69%)  9/124 (7.26%) 
Diarrhoea  1  10/119 (8.40%)  13/122 (10.66%)  10/124 (8.06%) 
Constipation  1  2/119 (1.68%)  5/122 (4.10%)  4/124 (3.23%) 
Vomiting  1  3/119 (2.52%)  3/122 (2.46%)  3/124 (2.42%) 
Abdominal pain upper  1  1/119 (0.84%)  4/122 (3.28%)  3/124 (2.42%) 
Abdominal discomfort  1  1/119 (0.84%)  2/122 (1.64%)  3/124 (2.42%) 
Dyspepsia  1  0/119 (0.00%)  3/122 (2.46%)  0/124 (0.00%) 
Gastritis  1  2/119 (1.68%)  0/122 (0.00%)  1/124 (0.81%) 
Toothache  1  2/119 (1.68%)  1/122 (0.82%)  0/124 (0.00%) 
Abdominal distension  1  0/119 (0.00%)  2/122 (1.64%)  0/124 (0.00%) 
Dry mouth  1  0/119 (0.00%)  1/122 (0.82%)  1/124 (0.81%) 
Haematochezia  1  1/119 (0.84%)  0/122 (0.00%)  1/124 (0.81%) 
Stomatitis  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Dental caries  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Epigastric discomfort  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Haemorrhoids  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Hypoaesthesia oral  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Salivary hypersecretion  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
General disorders       
Thirst  1  3/119 (2.52%)  5/122 (4.10%)  3/124 (2.42%) 
Feeling abnormal  1  0/119 (0.00%)  2/122 (1.64%)  2/124 (1.61%) 
Fatigue  1  0/119 (0.00%)  3/122 (2.46%)  0/124 (0.00%) 
Malaise  1  1/119 (0.84%)  0/122 (0.00%)  1/124 (0.81%) 
Oedema peripheral  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Chest discomfort  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Chest pain  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Facial pain  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Irritability  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Non-cardiac chest pain  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Pyrexia  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  2/119 (1.68%)  0/122 (0.00%)  1/124 (0.81%) 
Immune system disorders       
Seasonal allergy  1  1/119 (0.84%)  0/122 (0.00%)  3/124 (2.42%) 
Infections and infestations       
Nasopharyngitis  1  24/119 (20.17%)  17/122 (13.93%)  21/124 (16.94%) 
Gastroenteritis  1  0/119 (0.00%)  0/122 (0.00%)  3/124 (2.42%) 
Oral herpes  1  0/119 (0.00%)  2/122 (1.64%)  0/124 (0.00%) 
Pharyngitis  1  0/119 (0.00%)  1/122 (0.82%)  1/124 (0.81%) 
Cystitis  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Gingivitis  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Herpes zoster  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Laryngitis  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Otitis media  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Otitis media chronic  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Pericoronitis  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Periodontitis  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Respiratory tract infection viral  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Varicella  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Viral rash  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Injury, poisoning and procedural complications       
Road traffic accident  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Accidental overdose  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Arthropod bite  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Arthropod sting  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Brain contusion  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Heat stroke  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Laceration  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Procedural dizziness  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Investigations       
Blood creatine phosphokinase increased  1  5/119 (4.20%)  1/122 (0.82%)  5/124 (4.03%) 
Blood triglycerides increased  1  3/119 (2.52%)  0/122 (0.00%)  5/124 (4.03%) 
Alanine aminotransferase increased  1  0/119 (0.00%)  3/122 (2.46%)  1/124 (0.81%) 
Liver function test abnormal  1  1/119 (0.84%)  2/122 (1.64%)  1/124 (0.81%) 
Blood bilirubin increased  1  1/119 (0.84%)  2/122 (1.64%)  0/124 (0.00%) 
Blood uric acid increased  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Blood urine present  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Gamma-glutamyltransferase increased  1  0/119 (0.00%)  1/122 (0.82%)  1/124 (0.81%) 
Weight decreased  1  1/119 (0.84%)  0/122 (0.00%)  1/124 (0.81%) 
Aspartate aminotransferase increased  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Blood cholesterol increased  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Glucose urine present  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Low density lipoprotein increased  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Platelet count decreased  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Transaminases increased  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Weight increased  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
White blood cell count decreased  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
White blood cell count increased  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  2/119 (1.68%)  0/122 (0.00%)  0/124 (0.00%) 
Dehydration  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Dyslipidaemia  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Hyperlipidaemia  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/119 (0.00%)  3/122 (2.46%)  1/124 (0.81%) 
Myalgia  1  0/119 (0.00%)  1/122 (0.82%)  1/124 (0.81%) 
Muscle fatigue  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Muscle tightness  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Musculoskeletal stiffness  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Neck pain  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer recurrent  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Nervous system disorders       
Somnolence  1  7/119 (5.88%)  12/122 (9.84%)  9/124 (7.26%) 
Headache  1  10/119 (8.40%)  6/122 (4.92%)  8/124 (6.45%) 
Dizziness  1  2/119 (1.68%)  5/122 (4.10%)  2/124 (1.61%) 
Dizziness postural  1  1/119 (0.84%)  1/122 (0.82%)  0/124 (0.00%) 
Dysgeusia  1  0/119 (0.00%)  2/122 (1.64%)  0/124 (0.00%) 
Amnesia  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Cerebral haematoma  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Head discomfort  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Hypoaesthesia  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Memory impairment  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Paraesthesia  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Restless legs syndrome  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Subarachnoid haemorrhage  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Tension headache  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Psychiatric disorders       
Suicidal ideation  1  1/119 (0.84%)  8/122 (6.56%)  2/124 (1.61%) 
Insomnia  1  2/119 (1.68%)  1/122 (0.82%)  1/124 (0.81%) 
Nightmare  1  0/119 (0.00%)  2/122 (1.64%)  1/124 (0.81%) 
Agitation  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Initial insomnia  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Self injurious behaviour  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Suicidal behaviour  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Renal and urinary disorders       
Dysuria  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Pollakiuria  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Menstruation irregular  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic pharyngitis  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Asthma  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Oropharyngeal pain  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Rhinitis allergic  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Rhinorrhoea  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  4/119 (3.36%)  1/122 (0.82%)  0/124 (0.00%) 
Pruritus  1  1/119 (0.84%)  1/122 (0.82%)  1/124 (0.81%) 
Acne  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Dermatitis  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Dermatitis contact  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Erythema  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Heat rash  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Papule  1  0/119 (0.00%)  1/122 (0.82%)  0/124 (0.00%) 
Prurigo  1  0/119 (0.00%)  0/122 (0.00%)  1/124 (0.81%) 
Seborrhoeic dermatitis  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Urticaria  1  1/119 (0.84%)  0/122 (0.00%)  0/124 (0.00%) 
Vascular disorders       
Hypertension  1  1/119 (0.84%)  3/122 (2.46%)  0/124 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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
Layout table for Results Point of Contact information
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01355081     History of Changes
Other Study ID Numbers: LuAA21004/CCT-003
U1111-1120-9277 ( Registry Identifier: WHO )
JapicCTI-111492 ( Registry Identifier: JapicCTI )
First Submitted: May 16, 2011
First Posted: May 17, 2011
Results First Submitted: November 4, 2014
Results First Posted: November 11, 2014
Last Update Posted: November 11, 2014