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Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)

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ClinicalTrials.gov Identifier: NCT00996944
Recruitment Status : Terminated (Because GSK concluded that it was impossible to recruit sufficient participants within a reasonable timeframe.)
First Posted : October 16, 2009
Results First Posted : June 13, 2011
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: Ropinirole immediate release (IR)
Drug: Placebo
Enrollment 34
Recruitment Details This study was prematurely terminated after 5 months had passed since its initiation, because GlaxoSmithKline (GSK) concluded that it was impossible to recruit sufficient participants within a reasonable timeframe. In this study, no participants had completed. The maximum duration was 24 weeks plus follow-up (up to Week 64).
Pre-assignment Details  
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period. Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Period Title: Double-blind Treatment Period
Started 22 12
Completed 12 5
Not Completed 10 7
Reason Not Completed
Adverse Event             2             1
Protocol Violation             1             0
Study Closed/Terminated             6             5
Withdrawal by Subject             1             1
Period Title: Long-term Treatment Period
Started 12 5
Completed 0 0
Not Completed 12 5
Reason Not Completed
Study Closed/Terminated             12             5
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR Total
Hide Arm/Group Description Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period. Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group. Total of all reporting groups
Overall Number of Baseline Participants 22 12 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 12 participants 34 participants
53.5  (11.39) 53.8  (10.90) 53.6  (11.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 12 participants 34 participants
Female
3
  13.6%
4
  33.3%
7
  20.6%
Male
19
  86.4%
8
  66.7%
27
  79.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 12 participants 34 participants
Asian - Japanese Heritage 22 12 34
Not Asian - Japanese Heritage 0 0 0
Age at Onset of Restless Legs Syndrome  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 12 participants 34 participants
48.9  (11.24) 49.4  (10.12) 49.1  (10.71)
Duration of Dialysis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 12 participants 34 participants
7.41  (5.537) 6.08  (5.274) 6.94  (5.403)
1.Primary Outcome
Title International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12
Hide Description The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 22 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0, n=22, 12 26.0  (5.51) 24.0  (3.64)
Week 12, n=12, 5 15.9  (9.97) 9.2  (5.26)
2.Primary Outcome
Title IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.3  (10.77) 16.3  (10.42)
3.Secondary Outcome
Title IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)
Hide Description The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.0  (12.26) 16.5  (4.12)
4.Secondary Outcome
Title Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Hide Description The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 12 5
Measure Type: Number
Unit of Measure: participants
Not Assessed 0 0
Very Much Improved 2 3
Much Improved 3 1
Minimally Improved 4 1
No Change 2 0
Minimally Worse 1 0
Much Worse 0 0
Very Much Worse 0 0
5.Secondary Outcome
Title Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with missing DBT WD data were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 8 7
Measure Type: Number
Unit of Measure: participants
Not Assessed 0 0
Very Much Improved 0 1
Much Improved 3 2
Minimally Improved 2 3
No Change 2 0
Minimally Worse 0 0
Much Worse 1 0
Very Much Worse 0 1
6.Secondary Outcome
Title Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Hide Description The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 11 4
Measure Type: Number
Unit of Measure: participants
Not Assessed 0 0
Very Much Improved 3 0
Much Improved 1 2
Minimally Improved 4 2
No Change 0 0
Minimally Worse 3 0
Much Worse 0 0
Very Much Worse 0 0
7.Secondary Outcome
Title Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12
Hide Description The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 22 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0, n=22, 12 77.50  (15.736) 73.13  (10.287)
Week 12, n=12, 5 85.63  (14.852) 90.50  (7.786)
8.Secondary Outcome
Title Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with missing DBT WD data were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.00  (12.956) 84.64  (9.835)
9.Secondary Outcome
Title Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)
Hide Description The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.32  (27.502) 87.50  (11.365)
10.Secondary Outcome
Title The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12
Hide Description The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 22 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0, n=22, 12 10.3  (2.98) 10.5  (3.71)
Week 12, n=12, 5 7.3  (2.90) 8.6  (2.51)
11.Secondary Outcome
Title The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with missing DBT WD data were not included in this analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.8  (3.54) 7.3  (3.15)
12.Secondary Outcome
Title The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Hide Description The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (3.57) 9.3  (3.10)
13.Secondary Outcome
Title Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Hide Description Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 22 12
Measure Type: Number
Unit of Measure: participants
Week 0, n=22,12; Very satisfied 0 1
Week 0, n=22, 12; Satisfied 3 6
Week 0, n=22, 12; Somewhat satisfied 4 2
Week 0, n=22, 12; Neither satisfied/dissatisfied 10 2
Week 0, n=22, 12; Somewhat dissatisfied 1 1
Week 0, n=22, 12; Dissatisfied 3 0
Week 0, n=22, 12; Very dissatisfied 1 0
Week 12, n=12, 5; Very satisfied 0 0
Week 12, n=12, 5; Satisfied 4 3
Week 12, n=12, 5; Somewhat satisfied 0 1
Week 12, n=12, 5; Neither satisfied/dissatisfied 3 1
Week 12, n=12, 5; Somewhat dissatisfied 1 0
Week 12, n=12, 5; Dissatisfied 3 0
Week 12, n=12, 5, Very dissatisfied 1 0
14.Secondary Outcome
Title Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Hide Description Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 11 4
Measure Type: Number
Unit of Measure: participants
Very satisfied 0 1
Satisfied 2 0
Somewhat satisfied 3 1
Neither satisfied/dissatisfied 2 1
Somewhat dissatisfied 0 1
Dissatisfied 2 0
Very dissatisfied 2 0
15.Secondary Outcome
Title Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants with missing DBT WD data were not included in the analysis.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 8 7
Measure Type: Number
Unit of Measure: participants
Very satisfied 2 2
Satisfied 0 1
Somewhat satisfied 1 0
Neither satisfied/dissatisfied 3 2
Somewhat dissatisfied 1 1
Dissatisfied 0 0
Very dissatisfied 1 1
16.Secondary Outcome
Title Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Hide Description Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 21 12
Mean (Standard Deviation)
Unit of Measure: hours
Daytime, Week 0, n=16, 9 1.794  (1.6875) 1.857  (1.9437)
Daytime, Week 12, n=7, 3 1.482  (1.3927) 0.735  (0.3841)
Evening, Week 0, n=11, 9 1.296  (0.7910) 1.148  (0.8170)
Evening, Week 12, n=6, 2 1.097  (0.9323) 0.783  (0.3064)
Nighttime, Week 0, n=21, 12 2.256  (1.5310) 2.318  (2.3618)
Nighttime, Week 12, n=9, 4 1.726  (1.4537) 1.688  (1.1607)
17.Secondary Outcome
Title Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Hide Description Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Time Frame DBT WD (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: hours
Daytime, n=1, 2 9.590 [1]   (NA) 2.900  (3.6770)
Evening, n=1, 1 2.590 [1]   (NA) 2.590 [1]   (NA)
Nighttime, n=3, 2 1.802  (2.7692) 2.936  (3.1422)
[1]
Only one participant was analyzed in this group at this time point.
18.Secondary Outcome
Title Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Hide Description Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Time Frame LONG WD (up to Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: hours
Daytime, n=0, 2 NA [1]   (NA) 0.883  (0.7778)
Evening, n=1, 2 0.200 [2]   (NA) 1.948  (0.6399)
Nighttime, n=2, 1 2.432  (2.9446) 0.867 [2]   (NA)
[1]
No participants were analyzed in this group at this time point.
[2]
Only one participant was analyzed in this group at this time point.
19.Secondary Outcome
Title Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period)
Hide Description For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.
Time Frame Week 12 through Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description:
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Hide Arm/Group Description Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period. Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
All-Cause Mortality
Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   1/12 (8.33%) 
Cardiac disorders     
Acute coronary syndrome  1  1/22 (4.55%)  0/12 (0.00%) 
Atrial flutter  1  0/22 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Upper respiratory tract infection  1  0/22 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ropinirole IR-Ropinirole IR Placebo-Ropinirole IR
Affected / at Risk (%) Affected / at Risk (%)
Total   16/22 (72.73%)   10/12 (83.33%) 
Ear and labyrinth disorders     
Ear pain  1  0/22 (0.00%)  1/12 (8.33%) 
Tinnitus  1  0/22 (0.00%)  1/12 (8.33%) 
Eye disorders     
Conjunctivitis  1  0/22 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders     
Nausea  1  3/22 (13.64%)  1/12 (8.33%) 
Diarrhoea  1  2/22 (9.09%)  1/12 (8.33%) 
Abdominal discomfort  1  2/22 (9.09%)  0/12 (0.00%) 
Vomiting  1  2/22 (9.09%)  0/12 (0.00%) 
Abdominal pain  1  0/22 (0.00%)  1/12 (8.33%) 
Abdominal pain upper  1  0/22 (0.00%)  1/12 (8.33%) 
Constipation  1  0/22 (0.00%)  1/12 (8.33%) 
Duodenitis  1  0/22 (0.00%)  1/12 (8.33%) 
Gastritis  1  0/22 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Nasopharyngitis  1  9/22 (40.91%)  6/12 (50.00%) 
Gastroenteritis  1  2/22 (9.09%)  0/12 (0.00%) 
Hordeolum  1  0/22 (0.00%)  1/12 (8.33%) 
Upper respiratory tract infection  1  0/22 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications     
Contusion  1  1/22 (4.55%)  1/12 (8.33%) 
Shunt occlusion  1  1/22 (4.55%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  0/22 (0.00%)  1/12 (8.33%) 
Osteoarthritis  1  0/22 (0.00%)  1/12 (8.33%) 
Tenosynovitis  1  0/22 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Headache  1  1/22 (4.55%)  0/12 (0.00%) 
Somnolence  1  0/22 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Orthostatic hypotension  1  2/22 (9.09%)  1/12 (8.33%) 
Hypertension  1  2/22 (9.09%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
This study has not been published in the scientific literature.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00996944    
Other Study ID Numbers: 113079
First Submitted: October 8, 2009
First Posted: October 16, 2009
Results First Submitted: February 10, 2011
Results First Posted: June 13, 2011
Last Update Posted: August 10, 2018