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36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

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ClinicalTrials.gov Identifier: NCT02106442
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : July 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoporosis
Intervention Drug: Sodium risedronate
Enrollment 579
Recruitment Details Participants took part in the survey at 148 investigative sites in Japan, from 13 May 2013 to 30 April 2018.
Pre-assignment Details Participants with a historical diagnosis of osteoporosis were enrolled. Participants received interventions as part of routine medical care.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description 75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Period Title: Overall Study
Started 579
Completed 542
Not Completed 37
Reason Not Completed
Case Report Forms Uncollected             7
Protocol Deviation             30
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description 75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Baseline Participants 542
Hide Baseline Analysis Population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 541 participants
75.9  (8.0)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Female
479
  88.4%
Male
63
  11.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 542 participants
542
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 304 participants
148.65  (7.88)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 348 participants
50.37  (11.79)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
BMI   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/meters (m)^2
Number Analyzed 277 participants
22.81  (4.81)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Osteoporosis Class  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Primary Osteoporosis
481
  88.7%
Secondary Osteoporosis
28
   5.2%
Unknown
33
   6.1%
Duration of Diagnosis of Osteoporosis   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 462 participants
1.5  (2.8)
[1]
Measure Description: Mean duration from the first time of diagnosis of osteoporosis to the start of the study was reported.
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Predisposition to Hypersensitivity
32
   5.9%
Had No Predisposition to Hypersensitivity
457
  84.3%
Unknown
53
   9.8%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Medical Complications
453
  83.6%
Had No Medical Complications
89
  16.4%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Medical History, Excluding History of Fracture   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Medical History
111
  20.5%
Had No Medical History
397
  73.2%
Unknown
34
   6.3%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Fracture Risk Factor: Medical History of Fracture  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Medical History
305
  56.3%
Had No Medical History
212
  39.1%
Unknown
25
   4.6%
Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had History of Steroid Use
35
   6.5%
Had No History of Steroid Use
477
  88.0%
Unknown
30
   5.5%
Fracture Risk Factor: Parental History of Femur Fracture  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Family History of Femur Fracture
5
   0.9%
Had No Family History of Femur Fracture
243
  44.8%
Unknown
294
  54.2%
Fracture Risk Factor: Alcohol Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Drank >= 3 Units Daily
27
   5.0%
Drank <3 Units Daily
356
  65.7%
Unknown
159
  29.3%
Fracture Risk Factor: Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Never Smoked
324
  59.8%
Current Smoker
22
   4.1%
Ex-Smoker
21
   3.9%
Unknown
175
  32.3%
Previous Medication for Osteoporosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Previous Medication for Osteoporosis
201
  37.1%
Had No Previous Medication for Osteoporosis
341
  62.9%
Concurrent Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Concurrent Medication
452
  83.4%
Had No Concurrent Medication
90
  16.6%
Physical Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Physical Therapy
178
  32.8%
Had No Physical Therapy
364
  67.2%
Other Concurrent Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Other Concurrent Therapy
164
  30.3%
Had No Other Concurrent Therapy
378
  69.7%
[1]
Measure Description: Other concurrent therapy included diet therapy, exercise therapy, and nerve block.
Back Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants
Had Back Pain
346
  63.8%
Had No Back Pain
97
  17.9%
Unknown
99
  18.3%
1.Primary Outcome
Title Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Hide Description The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time Frame From baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Vertebral fractures assessment population; The vertebral fractures assessment population was defined as participants who completed the survey and had evaluable vertebral fractures data at baseline and post-baseline time points. Number analyzed is the number of participants who were evaluable at each time point.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 328
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Month 6 Number Analyzed 254 participants
5.43
(3.36 to 8.72)
Month 12 Number Analyzed 227 participants
7.35
(4.85 to 11.06)
Month 18 Number Analyzed 192 participants
7.80
(5.20 to 11.64)
Month 24 Number Analyzed 172 participants
8.82
(5.97 to 12.93)
Month 30 Number Analyzed 142 participants
9.97
(6.84 to 14.43)
Month 36 Number Analyzed 69 participants
12.58
(8.61 to 18.18)
2.Secondary Outcome
Title Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Hide Description The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time Frame From baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 535
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Month 6 Number Analyzed 401 participants
1.72
(0.86 to 3.41)
Month 12 Number Analyzed 348 participants
2.78
(1.58 to 4.86)
Month 18 Number Analyzed 284 participants
3.40
(2.01 to 5.71)
Month 24 Number Analyzed 259 participants
4.11
(2.51 to 6.69)
Month 30 Number Analyzed 218 participants
6.15
(3.99 to 9.43)
Month 36 Number Analyzed 133 participants
6.59
(4.31 to 10.01)
3.Secondary Outcome
Title Cumulative Percentage of Participants With Femur Fractures
Hide Description The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time Frame From baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 535
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Month 6 Number Analyzed 407 participants
0.19
(0.03 to 1.35)
Month 12 Number Analyzed 355 participants
0.46
(0.11 to 1.84)
Month 18 Number Analyzed 290 participants
0.78
(0.25 to 2.46)
Month 24 Number Analyzed 266 participants
1.14
(0.42 to 3.08)
Month 30 Number Analyzed 228 participants
1.14
(0.42 to 3.08)
Month 36 Number Analyzed 139 participants
1.58
(0.64 to 3.88)
4.Secondary Outcome
Title Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
Hide Description BMD was measured by dual-energy X-ray absorptiometry.
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: Percent Change
6.848  (8.971)
5.Secondary Outcome
Title Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
Hide Description BMD was measured by dual-energy X-ray absorptiometry.
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: Percent Change
1.067  (6.757)
6.Secondary Outcome
Title Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
Hide Description BMD was measured by dual-energy X-ray absorptiometry.
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: Percent Change
1.496  (6.841)
7.Secondary Outcome
Title Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
Hide Description BMD was measured by dual-energy X-ray absorptiometry.
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: Percent Change
3.498  (10.608)
8.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: Percent Change
-15.756  (26.386)
9.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: Percent Change
-15.539  (130.961)
10.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: Percent Change
-20.023  (23.160)
11.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: Percent Change
-40.838  (40.776)
12.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Percent Change
-25.285  (62.112)
13.Secondary Outcome
Title Change From Baseline in Height at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 164
Mean (Standard Deviation)
Unit of Measure: Centimeter
-0.82  (1.35)
14.Secondary Outcome
Title Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Hide Description [Not Specified]
Time Frame Final assessment (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 376
Measure Type: Count of Participants
Unit of Measure: Participants
116
  30.9%
15.Secondary Outcome
Title Number of Participants Who Had One or More Adverse Drug Reactions
Hide Description Adverse drug reaction refers to adverse events related to the administered drug.
Time Frame Up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
Overall Number of Participants Analyzed 542
Measure Type: Count of Participants
Unit of Measure: Participants
57
  10.5%
Time Frame Up to Month 36
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
 
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description 75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
All-Cause Mortality
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   0/542 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   4/542 (0.74%) 
Gastrointestinal disorders   
Toothache  1  1/542 (0.18%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/542 (0.18%) 
Musculoskeletal and connective tissue disorders   
Osteonecrosis  1  1/542 (0.18%) 
Surgical and medical procedures   
Hospitalisation  1  1/542 (0.18%) 
1
Term from vocabulary, MedDRA/J ver. 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   7/542 (1.29%) 
Gastrointestinal disorders   
Nausea  1  7/542 (1.29%) 
1
Term from vocabulary, MedDRA/J ver. 21.0
Indicates events were collected by systematic assessment
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
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02106442     History of Changes
Other Study ID Numbers: 178-002
JapicCTI-142479 ( Registry Identifier: JapicCTI )
First Submitted: April 3, 2014
First Posted: April 8, 2014
Results First Submitted: April 23, 2019
Results First Posted: July 17, 2019
Last Update Posted: July 30, 2019