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Trial record 19 of 27 for:    PDSS2

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01628926
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: SPM 962
Drug: Ropinirole
Drug: Placebo
Enrollment 420
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description SPM 962 transdermal patch Ropinirole tablet SPM962 placebo patch and Ropinirole placebo tab
Period Title: Overall Study
Started 168 167 85
Completed 142 144 68
Not Completed 26 23 17
Reason Not Completed
Adverse Event             13             11             9
Lack of Efficacy             2             1             5
Withdrawal by Subject             6             4             2
Protocol Violation             0             1             0
Discontinuation criteria             3             4             0
Physician Decision             2             2             1
Arm/Group Title SPM 962 Ropinirole Placebo Total
Hide Arm/Group Description SPM 962 transdermal patch Ropinirole tablet SPM962 placebo patch and Ropinirole placebo tab Total of all reporting groups
Overall Number of Baseline Participants 164 166 84 414
Hide Baseline Analysis Population Description
6 subjects were excluded. Met the exclusion criteria: 2 of SPM962, 1 of ropinirole Lack of efficacy observation: 2 of SPM962, 1 of Placebo
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 84 participants 414 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
71
  43.3%
52
  31.3%
28
  33.3%
151
  36.5%
>=65 years
93
  56.7%
114
  68.7%
56
  66.7%
263
  63.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 166 participants 84 participants 414 participants
64.8  (8.8) 67.0  (7.9) 65.3  (7.9) 65.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 84 participants 414 participants
Female
103
  62.8%
98
  59.0%
42
  50.0%
243
  58.7%
Male
61
  37.2%
68
  41.0%
42
  50.0%
171
  41.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 164 participants 166 participants 84 participants 414 participants
164 166 84 414
1.Primary Outcome
Title Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
Hide Description

Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.

UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Time Frame baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), last observation carried forward (LOCF)
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 164 166 84
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-10.9  (8.1) -9.5  (8.7) -4.5  (9.7)
2.Secondary Outcome
Title UPDRS Part 3 Sum Score
Hide Description

Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.

UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Time Frame baseline, 8 and 10 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 164 166 84
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
8 weeks after dosing -9.7  (7.2) -8.4  (8.1) -5.5  (8.3)
10 weeks after dosing -9.9  (7.1) -8.8  (8.3) -5.3  (9.0)
3.Secondary Outcome
Title UPDRS Part 2 Sum Score
Hide Description

Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.

UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 163 166 84
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.6  (4.1) -2.9  (3.5) -1.3  (3.4)
4.Secondary Outcome
Title Off Time
Hide Description Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS subjects with measurable off time data at baseline, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 111 113 57
Mean (Standard Deviation)
Unit of Measure: Hours/day
-1.3  (2.9) -2.0  (3.0) -0.4  (2.7)
5.Secondary Outcome
Title Parkinson's Disease Sleep Scale-2 (PDSS-2)
Hide Description Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 162 165 81
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.1  (6.8) -3.4  (7.6) -1.8  (7.0)
6.Secondary Outcome
Title On Time
Hide Description Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 164 165 83
Mean (Standard Deviation)
Unit of Measure: Hours/day
1.3  (2.7) 1.7  (2.9) 0.2  (2.6)
7.Secondary Outcome
Title On Time Without Dyskinesia Disturbing Daily Activities
Hide Description

Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.

On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.

Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 164 165 83
Mean (Standard Deviation)
Unit of Measure: Hours/day
1.1  (2.9) 1.6  (3.0) 0.3  (2.6)
8.Secondary Outcome
Title On Time With Dyskinesia Disturbing Daily Activities
Hide Description Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab.
Overall Number of Participants Analyzed 37 21 5
Mean (Standard Deviation)
Unit of Measure: Hours
1.3  (11.0) 0.6  (7.8) -0.2  (1.4)
9.Secondary Outcome
Title Effective Rate in UPDRS Part 3 Sum Score
Hide Description Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 164 166 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
≥20% decrease
80.5
(74.4 to 86.6)
69.1
(62.0 to 76.1)
56.6
(46.0 to 67.3)
≥30% decrease
69.5
(62.5 to 76.6)
60.6
(53.2 to 68.1)
39.8
(29.2 to 50.3)
10.Secondary Outcome
Title Effective Rate in UPDRS Part 2 Sum Score
Hide Description Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 163 166 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
≥20% decrease
65.2
(57.9 to 72.6)
56.7
(49.1 to 64.3)
47.0
(36.3 to 57.7)
≥30% decrease
55.9
(48.2 to 63.6)
43.3
(35.7 to 50.9)
28.9
(19.2 to 38.7)
11.Secondary Outcome
Title Effective Rate in Off Time
Hide Description

Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.

On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.

Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS subjects with measurable off time data at baseline, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 111 113 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
≥20% decrease
61.8
(52.7 to 70.9)
65.5
(56.7 to 74.3)
47.4
(34.4 to 60.3)
≥30% decrease
55.5
(46.2 to 64.7)
61.9
(53.0 to 70.9)
40.4
(27.6 to 53.1)
12.Secondary Outcome
Title Clinical Global Impression (CGI)
Hide Description

Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.

The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement.

Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 163 165 81
Measure Type: Number
Unit of Measure: Percentage of Participants
Decreased 50.3 49.1 30.9
Decreased (by at least 2 points) 8.0 8.5 3.7
Increased 3.1 4.2 4.9
Increased (by at least 2 points) 0 0 0
13.Secondary Outcome
Title Dystonia (at an Early Hour)
Hide Description Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab.
Overall Number of Participants Analyzed 163 165 81
Measure Type: Number
Unit of Measure: Percentage of participants
Decreased 10.4 10.9 7.4
Decreased (by at least 2 events) 1.8 4.2 2.5
Increased 1.2 3.0 3.7
Increased (by at least 2 events) 0 0.6 0
14.Secondary Outcome
Title Dystonia (in the Daytime)
Hide Description Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).
Time Frame Baseline, 16 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description:
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Overall Number of Participants Analyzed 163 165 81
Measure Type: Number
Unit of Measure: Percentage of Participants
Decreased 8.6 7.9 3.7
Decreased (by at least 2 events) 3.7 5.5 2.5
Increased 3.7 2.4 4.9
Increased (by at least 2 events) 1.8 0.6 1.2
Time Frame 21 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPM 962 Ropinirole Placebo
Hide Arm/Group Description SPM 962 transdermal patch Ropinirole tablet SPM962 placebo patch and Ropinirole placebo tab
All-Cause Mortality
SPM 962 Ropinirole Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SPM 962 Ropinirole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/168 (4.17%)      5/167 (2.99%)      6/85 (7.06%)    
Cardiac disorders       
Angina Pectoris * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
Gastrointestinal disorders       
Gastric Ulcer * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Gastric Ulcer Bleeding * 1  0/168 (0.00%)  0 1/167 (0.60%)  1 0/85 (0.00%)  0
Ileus * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis * 1  0/168 (0.00%)  0 1/167 (0.60%)  1 0/85 (0.00%)  0
Cholelithiasis * 1  0/168 (0.00%)  0 1/167 (0.60%)  1 0/85 (0.00%)  0
Infections and infestations       
Pneumonia * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
Urinary Tract Infection * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
Injury, poisoning and procedural complications       
Spinal Compression Fracture * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 1/85 (1.18%)  1
Femoral Neck Fracture * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Torticollis * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Carcinoma Gastric * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
Breast Cancer * 1  0/168 (0.00%)  0 1/167 (0.60%)  1 0/85 (0.00%)  0
Nervous system disorders       
Posture Abnormal * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Disease Parkinson's * 1  1/168 (0.60%)  1 1/167 (0.60%)  1 1/85 (1.18%)  1
Cerebral Artery Embolism * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
Psychiatric disorders       
Delusion * 1  0/168 (0.00%)  0 1/167 (0.60%)  1 0/85 (0.00%)  0
Renal and urinary disorders       
Caruncle Urethral * 1  1/168 (0.60%)  1 0/167 (0.00%)  0 0/85 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Embolism Pulmonary * 1  0/168 (0.00%)  0 0/167 (0.00%)  0 1/85 (1.18%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(13.1)J
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
SPM 962 Ropinirole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   140/168 (83.33%)      99/167 (59.28%)      40/85 (47.06%)    
Gastrointestinal disorders       
Nausea * 1  25/168 (14.88%)  27 23/167 (13.77%)  26 7/85 (8.24%)  8
Vomiting * 1  11/168 (6.55%)  15 11/167 (6.59%)  13 2/85 (2.35%)  2
General disorders       
Application Site Reaction * 1  91/168 (54.17%)  93 30/167 (17.96%)  33 10/85 (11.76%)  11
Application Site Pruritus * 1  6/168 (3.57%)  7 0/167 (0.00%)  0 0/85 (0.00%)  0
Oedema Peripheral * 1  0/168 (0.00%)  0 2/167 (1.20%)  2 3/85 (3.53%)  3
Infections and infestations       
Nasopharyngitis * 1  28/168 (16.67%)  38 24/167 (14.37%)  29 13/85 (15.29%)  17
Cystitis * 1  3/168 (1.79%)  3 3/167 (1.80%)  3 4/85 (4.71%)  5
Injury, poisoning and procedural complications       
Contusion * 1  7/168 (4.17%)  7 2/167 (1.20%)  2 6/85 (7.06%)  8
Investigations       
Blood Creatine Phosphokinase Increased * 1  5/168 (2.98%)  5 6/167 (3.59%)  6 1/85 (1.18%)  2
Musculoskeletal and connective tissue disorders       
Back Pain * 1  3/168 (1.79%)  3 5/167 (2.99%)  5 2/85 (2.35%)  2
Nervous system disorders       
Dyskinesia * 1  27/168 (16.07%)  28 23/167 (13.77%)  23 1/85 (1.18%)  1
Psychiatric disorders       
Hallucination Visual * 1  13/168 (7.74%)  14 10/167 (5.99%)  10 3/85 (3.53%)  3
Somnolence * 1  11/168 (6.55%)  11 9/167 (5.39%)  9 2/85 (2.35%)  2
Hallucination * 1  3/168 (1.79%)  3 6/167 (3.59%)  6 0/85 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Tract Inflammation * 1  3/168 (1.79%)  4 1/167 (0.60%)  1 3/85 (3.53%)  4
Vascular disorders       
Orthostatic Hypotension * 1  5/168 (2.98%)  5 7/167 (4.19%)  8 4/85 (4.71%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(13.1)J
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co, Lts.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01628926     History of Changes
Other Study ID Numbers: 243-08-001
JapicCTI-090888 ( Other Identifier: JAPIC )
First Submitted: June 24, 2012
First Posted: June 27, 2012
Results First Submitted: February 3, 2014
Results First Posted: May 23, 2014
Last Update Posted: May 23, 2014