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This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropinirole CR-RLS | Experimental | Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropinirole controlled release (CR)-RLS | Drug | White film-coated round-shaped tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Related Adverse Events-On-Therapy | Weeks 1 - 12 Treatment Period | |
| Haematology Clinical Lab Values Change From Baseline | Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal. | Baseline - Week 13 (Follow-up) |
| Blood Chemistry Clinical Lab Values Change From Baseline | Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L | Baseline - Week 13 (Follow-up) |
| Urinalysis Clinical Lab Values | Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3. | Baseline - Week 13 (Follow-up) |
| 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline | Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS. | Baseline, Week 4, 8, 12, 13 (Follow-up) |
| Vital Signs and Body Weight Change From Baseline | Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score | The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points. |
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Inclusion Criteria:
At Week -1 (at the start of Screening period)
Patients who are diagnosed with RLS according to the International RLS Study Group's (IRLSSG) Diagnostic Criteria.
Age: Patients aged at least 18 years and under 80 years.
Patients who have had RLS symptoms in the evening or nighttime (17:00 to 7:00 next day) for at least 20 days within one month before the start of the screening period. Patients treated for RLS before the start of the Screening period and who do not meet this criterion are considered eligible if the previous therapy can be discontinued from the Screening period.
Patients who experience RLS symptoms requiring treatment after 17:00 but prior to bedtime.
Gender: male and female Female of child-bearing potential will be eligible for inclusion in this study. However they must have a negative pregnancy test at the Screening visit. They agree are perform pregnancy test at the time determined and practice one of the following method of contraception from the Screening visit till the end of follow-up examination.
Inpatient or outpatient status: Outpatient status
Patients who are able to give informed written consent in person. For patients aged under 20 years, their legally acceptable representatives are able to give informed written consent.
At Week 0 (at the start of treatment period)
Exclusion Criteria:
The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (Pharmaceutical affairs Bureau/Safety Division (PAB/SD) Notification No. 80, dated 29 June 1992).
Augmentation is defined as below:
RLS appear 2 hours earlier than the pre-treatment. Symptoms become severer than the pre-treatment. Symptoms which start after less time at rest than they did before treatment. The RLS extend to other sites (e.g. arm and trunk).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 802-0084 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107846 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropinirole CR-RLS | Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropinirole CR-RLS | Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug Related Adverse Events-On-Therapy | Safety Population consisting of the subjects who took at least one dose of the study medication. | Posted | Number | Number of Events | Weeks 1 - 12 Treatment Period |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropinirole CR-RLS | Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Baseline to Week 12/EW |
| Baseline and after Week 12 |
| Clinical Global Impression Scale - Severity of Illness (CGI-S) | The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7). | Baseline - Final assessment point |
| Clinical Global Impression Global Improvement (CGI-GI) | CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7). | Baseline - Final assessment point |
| Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score | The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance. | Baseline - Week 12/EW |
| Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains | The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance. | Baseline - Week 12/EW |
| Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score | The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47 | Baseline and Week 12/EW |
| Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS) | The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors:
| Baseline and Week 12/EW |
| Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS) | Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation. | Baseline - Week 12/EW |
| Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | Weeks 1-12 |
| Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | Weeks 1 -12 |
| Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | Weeks 1-12 |
| Fukuoka |
| 810-0044 |
| Japan |
| GSK Investigational Site | Fukuoka | 830-0011 | Japan |
| GSK Investigational Site | Hiroshima | 733-0031 | Japan |
| GSK Investigational Site | Kanagawa | 210-0024 | Japan |
| GSK Investigational Site | Osaka | 550-0004 | Japan |
| GSK Investigational Site | Osaka | 589-0022 | Japan |
| GSK Investigational Site | Osaka | 599-8263 | Japan |
| GSK Investigational Site | Tochigi | 321-0293 | Japan |
| GSK Investigational Site | Tokyo | 151-0053 | Japan |
| GSK Investigational Site | Tokyo | 187-0041 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107846 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107846 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107846 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Number of participants |
|
|
|
| Secondary | Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score | The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points. | Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | Points on a scale | Baseline and after Week 12 |
|
|
|
| Secondary | Clinical Global Impression Scale - Severity of Illness (CGI-S) | The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7). | Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF. | Posted | Number | Participants | Baseline - Final assessment point |
|
|
|
| Secondary | Clinical Global Impression Global Improvement (CGI-GI) | CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7). | Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF. | Posted | Number | Participants | Baseline - Final assessment point |
|
|
|
| Secondary | Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score | The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance. | Full Analysis Set(FAS) | Posted | Mean | Standard Deviation | Points on a scale | Baseline - Week 12/EW |
|
|
|
| Secondary | Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains | The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance. | Full Analysis Set(FAS) | Posted | Mean | Standard Deviation | Points on a scale | Baseline - Week 12/EW |
|
|
|
| Secondary | Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score | The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47 | Full Analysis Set(FAS) | Posted | Mean | Standard Deviation | Points on a scale | Baseline and Week 12/EW |
|
|
|
| Primary | Haematology Clinical Lab Values Change From Baseline | Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal. | Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated). | Posted | Mean | Standard Deviation | Varied Standard Units of Measure | Baseline - Week 13 (Follow-up) |
|
|
|
| Primary | Blood Chemistry Clinical Lab Values Change From Baseline | Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L | Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated). | Posted | Mean | Standard Deviation | Varied Standard Units of Measure | Baseline - Week 13 (Follow-up) |
|
|
|
| Primary | Urinalysis Clinical Lab Values | Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3. | Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 [Follow-up] = 35 subjects evaluated). | Posted | Number | Participants | Baseline - Week 13 (Follow-up) |
|
|
|
| Primary | 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline | Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS. | Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 [Follow-up] = 35 subjects evaluated). | Posted | Number | Participants | Baseline, Week 4, 8, 12, 13 (Follow-up) |
|
|
|
| Primary | Vital Signs and Body Weight Change From Baseline | Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing. | Safety Population | Posted | Mean | Standard Deviation | Varied Standard Units of Measure | Baseline to Week 12/EW |
|
|
|
| Secondary | Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS) | The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors:
| Full Analysis Set | Posted | Mean | Standard Deviation | Points on a scale | Baseline and Week 12/EW |
|
|
|
| Secondary | Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS) | Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation. | FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively. | Posted | Mean | Standard Deviation | Points on a scale | Baseline - Week 12/EW |
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| Secondary | Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation. | Posted | Mean | Standard Deviation | picograms/mL | Weeks 1-12 |
|
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| Secondary | Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | PK Population | Posted | Mean | Standard Deviation | picograms/mL | Weeks 1 -12 |
|
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| Secondary | Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole. | Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision. | PK Population | Posted | Mean | Standard Deviation | picograms/mL | Weeks 1-12 |
|
|
|
| 0 |
| 35 |
| 33 |
| 35 |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dizziness | General disorders | MedDRA | Systematic Assessment |
|
| Hypersomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal Pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Local Swelling | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Tenosynovitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Thirst | General disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Upper Respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Vertebral injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
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 the multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
|
| Title | Measurements |
|---|---|
|
| Baseline - Moderately |
|
| Baseline - Markedly |
|
| Baseline - Severely |
|
| Week 1 - Normal |
|
| Week 1 - Borderline |
|
| Week 1 - Mildly |
|
| Week 1 - Moderately |
|
| Week 1 - Markedly |
|
| Week 1 - Severely |
|
| Week 2 - Normal |
|
| Week 2 - Borderline |
|
| Week 2 - Mildly |
|
| Week 2 - Moderately |
|
| Week 2 - Markedly |
|
| Week 2 - Severely |
|
| Week 3 - Normal |
|
| Week 3 - Borderline |
|
| Week 3 - Mildly |
|
| Week 3 - Moderately |
|
| Week 3 - Markedly |
|
| Week 3 - Severely |
|
| Week 4 - Normal |
|
| Week 4 - Borderline |
|
| Week 4 - Mildly |
|
| Week 4 - Moderately |
|
| Week 4 - Markedly |
|
| Week 4 - Severely |
|
| Week 5 - Normal |
|
| Week 5 - Borderline |
|
| Week 5 - Mildly |
|
| Week 5 - Moderately |
|
| Week 5 - Markedly |
|
| Week 5 - Severely |
|
| Week 6 - Normal |
|
| Week 6 - Borderline |
|
| Week 6 - Mildly |
|
| Week 6 - Moderately |
|
| Week 6 - Markedly |
|
| Week 6 - Severely |
|
| Week 8 - Normal |
|
| Week 8 - Borderline |
|
| Week 8 - Mildly |
|
| Week 8 - Moderately |
|
| Week 8 - Markedly |
|
| Week 8 - Severely |
|
| Week 10 - Normal |
|
| Week 10 - Borderline |
|
| Week 10 - Mildly |
|
| Week 10 - Moderately |
|
| Week 10 - Markedly |
|
| Week 10 - Severely |
|
| Week 12 - Normal |
|
| Week 12 - Borderline |
|
| Week 12 - Mildly |
|
| Week 12 - Moderately |
|
| Week 12 - Markedly |
|
| Week 12 - Severely |
|
| Final assessment point - Normal |
|
| Final assessment point - Borderline |
|
| Final assessment point - Mildly |
|
| Final assessment point - Moderately |
|
| Final assessment point - Markedly |
|
| Final assessment point - Severely |
|
| Title | Measurements |
|---|---|
|
| Week 1 - No Change |
|
| Week 2 - Very Much Improved |
|
| Week 2 - Much Improved |
|
| Week 2 - Minimally Improved |
|
| Week 2 - No Change |
|
| Week 3 - Very Much Improved |
|
| Week 3 - Much Improved |
|
| Week 3 - Minimally Improved |
|
| Week 3 - No Change |
|
| Week 4 - Very Much Improved |
|
| Week 4 - Much Improved |
|
| Week 4 - Minimally Improved |
|
| Week 4 - No Change |
|
| Week 5 - Very Much Improved |
|
| Week 5 - Much Improved |
|
| Week 5 - Minimally Improved |
|
| Week 5 - No Change |
|
| Week 6 - Very Much Improved |
|
| Week 6 - Much Improved |
|
| Week 6 - Minimally Improved |
|
| Week 6 - No Change |
|
| Week 8 - Very Much Improved |
|
| Week 8 - Much Improved |
|
| Week 8 - Minimally Improved |
|
| Week 8 - No Change |
|
| Week 10 - Very Much Improved |
|
| Week 10 - Much Improved |
|
| Week 10 - Minimally Improved |
|
| Week 10 - No Change |
|
| Week 12 - Very Much Improved |
|
| Week 12 - Much Improved |
|
| Week 12 - Minimally Improved |
|
| Week 12 - No Change |
|
| Final assessment point - Very Much Improved |
|
| Final assessment point - Much Improved |
|
| Final assessment point - Minimally Improved |
|
| Final assessment point - No Change |
|
|
| Title | Measurements |
|---|---|
|
| Duration getting to sleep - Baseline |
|
| Duration getting to sleep - Week 12/EW |
|
| Duration getting to sleep - Change from Baseline |
|
| Sleep Duration - Baseline |
|
| Sleep Duration - Week 12/EW |
|
| Sleep Duration - Change from Baseline |
|
| Sleep Adequacy - Baseline |
|
| Sleep Adequacy - Week 12/EW |
|
| Sleep Adequacy - Change from Baseline |
|
| Sleep Disturbance - Baseline |
|
| Sleep Disturbance - Week 12/EW |
|
| Sleep Disturbance - Change from Baseline |
|
| Use of Sleeping pill - Baseline |
|
| Use of Sleeping pill - Week 12/EW |
|
| Use of Sleeping pill - Change from Baseline |
|
| Somnolence - Baseline |
|
| Somnolence - Week 12/EW |
|
| Somnolence - Change from Baseline |
|
|
| Title | Measurements |
|---|---|
|
| Hemoglobin (G/L) - week 12/EW |
|
| Hemoglobin (G/L)- week 13 |
|
| Hematocrit (SI) - week 4 |
|
| Hematocrit (SI) - week 8 |
|
| Hematocrit (SI) - week 12 |
|
| Hematocrit (SI) - week 12/EW |
|
| Hematocrit (SI) - week 13 |
|
| Platelet Count (GI/L) - week 4 |
|
| Platelet Count (GI/L) - week 8 |
|
| Platelet Count (GI/L) - week 12 |
|
| Platelet Count (GI/L) - week 12/EW |
|
| Platelet Count (GI/L) - week 13 |
|
| Red Blood Cell Count (TI/L) - week 4 |
|
| Red Blood Cell Count (TI/L) - week 8 |
|
| Red Blood Cell Count (TI/L) - week 12 |
|
| Red Blood Cell Count (TI/L) - week 12/EW |
|
| Red Blood Cell Count (TI/L) - week 13 |
|
| White Blood Cell Count (GI/L) - week 4 |
|
| White Blood Cell Count (GI/L) - week 8 |
|
| White Blood Cell Count (GI/L) - week 12 |
|
| White Blood Cell Count (GI/L) - week 12/EW |
|
| White Blood Cell Count (GI/L) - week 13 |
|
| Title | Measurements |
|---|---|
|
| Albumin (G/L) - week 12/EW |
|
| Albumin (G/L) - week 13 |
|
| Alkaline Phosphatase (IU/L) - week 4 |
|
| Alkaline Phosphatase (IU/L) - week 8 |
|
| Alkaline Phosphatase (IU/L) - week 12 |
|
| Alkaline Phosphatase (IU/L) - week 12/EW |
|
| Alkaline Phosphatase (IU/L) - week 13 |
|
| Alanine Amino Transferase (IU/L) - week 4 |
|
| Alanine Amino Transferase (IU/L) - week 8 |
|
| Alanine Amino Transferase (IU/L) - week 12 |
|
| Alanine Amino Transferase - week 12/EW |
|
| Alanine Amino Transferase - week 13 |
|
| Aspartate Amino Transferase(IU/L) - week 4 |
|
| Aspartate Amino Transferase (IU/L) - week 8 |
|
| Aspartate Amino Transferase (IU/L) - week 12 |
|
| Aspartate Amino Transferase (IU/L) - week 12/EW |
|
| Aspartate Amino Transferase (IU/L) - week 13 |
|
| Total Bilirubin (UMOL/L) - week 4 |
|
| Total Bilirubin (UMOL/L) - week 8 |
|
| Total Bilirubin (UMOL/L) - week 12 |
|
| Total Bilirubin (UMOL/L) - week 12/EW |
|
| Total Bilirubin (UMOL/L) - week 13 |
|
| Blood Urea Nitrogen (MMOL/L) - week 4 |
|
| Blood Urea Nitrogen (MMOL/L) - week 8 |
|
| Blood Urea Nitrogen (MMOL/L) - week 12 |
|
| Blood Urea Nitrogen (MMOL/L) - week 12/EW |
|
| Blood Urea Nitrogen (MMOL/L) - week 13 |
|
| Cholesterol (MMOL/L) - week 4 |
|
| Cholesterol (MMOL/L) - week 8 |
|
| Cholesterol (MMOL/L) - week 12 |
|
| Cholesterol (MMOL/L) - week 12/EW |
|
| Cholesterol - week 13 |
|
| Chloride(MMOL/L) - week 4 |
|
| Chloride (MMOL/L) - week 8 |
|
| Chloride (MMOL/L) - week 12 |
|
| Chloride (MMOL/L) - week 12/EW |
|
| Chloride (MMOL/L) - week 13 |
|
| Lactate Dehydrogenase (IU/L) - week 4 |
|
| Lactate Dehydrogenase (IU/L) - week 8 |
|
| Lactate Dehydrogenase (IU/L) - week 12 |
|
| Lactate Dehydrogenase (IU/L) - week 12/EW |
|
| Lactate Dehydrogenase (IU/L) - week 13 |
|
| Sodium (MMOL/L) - week 4 |
|
| Sodium (MMOL/L) - week 8 |
|
| Sodium (MMOL/L) - week 12 |
|
| Sodium (MMOL/L) - week 12/EW |
|
| Sodium (MMOL/L) - week 13 |
|
| Prolactin (MCG/L) - week 4 |
|
| Prolactin (MCG/L) - week 8 |
|
| Prolactin (MCG/L) - week 12 |
|
| Prolactin (MCG/L) - week 12/EW |
|
| Prolactin (MCG/L) - week 13 |
|
| Total Protein (G/L) - week 4 |
|
| Total Protein (G/L) - week 8 |
|
| Total Protein (G/L) - week 12 |
|
| Total Protein (G/L) - week 12/EW |
|
| Total Protein (G/L) - week 13 |
|
| Creatine Phosphokinase (IU/L) - week 4 |
|
| Creatine Phosphokinase (IU/L) - week 8 |
|
| Creatine Phosphokinase (IU/L) - week 12 |
|
| Creatine Phosphokinase (IU/L) - week 12/EW |
|
| Creatine Phosphokinase (IU/L) - week 13 |
|
| Creatinine (UMOL/L) - week 4 |
|
| Creatinine (UMOL/L) - week 8 |
|
| Creatinine (UMOL/L) - week 12 |
|
| Creatinine (UMOL/L) - week 12/EW |
|
| Creatinine (UMOL/L) - week 13 |
|
| Gamma Glutamyl Transferase (IU/L) - week 4 |
|
| Gamma Glutamyl Transferase (IU/L) - week 8 |
|
| Gamma Glutamyl Transferase (IU/L) - week 12 |
|
| Gamma Glutamyl Transferase (IU/L) - week 12/EW |
|
| Gamma Glutamyl Tranferase (IU/L) - week 13 |
|
| Potassium (MMOL/L) - week 4 |
|
| Potassium (MMOL/L) - week 8 |
|
| Potassium (MMOL/L) - week 12 |
|
| Potassium (MMOL/L) - week 12/EW |
|
| Potassium (MMOL/L) - week 13 |
|
| Title | Measurements |
|---|---|
|
| Urine Urobilinogen - Baseline: +2 |
|
| Urine Urobilinogen - Baseline: +3 |
|
| Urine Urobilinogen - week 4: Neg Value |
|
| Urine Urobilinogen - week 4: Trace |
|
| Urine Urobilinogen - week 4: +1 |
|
| Urine Urobilinogen - week 4: +2 |
|
| Urine Urobilinogen - week 4: +3 |
|
| Urine Urobilinogen - week 8: Neg Value |
|
| Urine Urobilinogen - week 8: Trace |
|
| Urine Urobilinogen - week 8: +1 |
|
| Urine Urobilinogen - week 8: +2 |
|
| Urine Urobilinogen - week 8: +3 |
|
| Urine Urobilinogen - week 12: Neg Value |
|
| Urine Urobilinogen - week 12: Trace |
|
| Urine Urobilinogen - week 12: +1 |
|
| Urine Urobilinogen - week 12: +2 |
|
| Urine Urobilinogen - week 12: +3 |
|
| Urine Urobilinogen - week 12/EW: Neg Value |
|
| Urine Urobilinogen - week 12/EW: Trace |
|
| Urine Urobilinogen - week 12/EW: +1 |
|
| Urine Urobilinogen - week 12/EW: +2 |
|
| Urine Urobilinogen - week 12/EW: +3 |
|
| Urine Urobilinogen - week 13: Neg Value |
|
| Urine Urobilinogen - week 13: Trace |
|
| Urine Urobilinogen - week 13: +1 |
|
| Urine Urobilinogen - week 13: +2 |
|
| Urine Urobilinogen - week 13: +3 |
|
| Urine Protein - Baseline: Neg Value |
|
| Urine Protein - Baseline: Trace |
|
| Urine Protein - Baseline: +1 |
|
| Urine Protein - Baseline: +2 |
|
| Urine Protein - Baseline: +3 |
|
| Urine Protein - Week 4: Neg Value |
|
| Urine Protein - Week 4: Trace |
|
| Urine Protein - Week 4: +1 |
|
| Urine Protein - Week 4: +2 |
|
| Urine Protein - Week 4: +3 |
|
| Urine Protein - Week 8: Neg Value |
|
| Urine Protein - Week 8: Trace |
|
| Urine Protein - Week 8: +1 |
|
| Urine Protein - Week 8: +2 |
|
| Urine Protein - Week 8: +3 |
|
| Urine Protein - Week 12: Neg Value |
|
| Urine Protein - Week 12: Trace |
|
| Urine Protein - Week 12: +1 |
|
| Urine Protein - Week 12: +2 |
|
| Urine Protein - Week 12: +3 |
|
| Urine Protein - Week 12/EW: Neg Value |
|
| Urine Protein - Week 12/EW: Trace |
|
| Urine Protein - Week 12/EW: +1 |
|
| Urine Protein - Week 12/EW: +2 |
|
| Urine Protein - Week 12/EW: +3 |
|
| Urine Protein - Week 13: Neg Value |
|
| Urine Protein - Week 13: Trace |
|
| Urine Protein - Week 13: +1 |
|
| Urine Protein - Week 13: +2 |
|
| Urine Protein - Week 13: +3 |
|
| Urine Occult Blood - Baseline: Neg Value |
|
| Urine Occult Blood - Baseline: Trace |
|
| Urine Occult Blood - Baseline: +1 |
|
| Urine Occult Blood - Baseline: +2 |
|
| Urine Occult Blood - Baseline: +3 |
|
| Urine Occult Blood - Week 4: Neg Value |
|
| Urine Occult Blood - Week 4: Trace |
|
| Urine Occult Blood - Week 4: +1 |
|
| Urine Occult Blood - Week 4: +2 |
|
| Urine Occult Blood - Week 4: +3 |
|
| Urine Occult Blood - Week 8: Neg Value |
|
| Urine Occult Blood - Week 8: Trace |
|
| Urine Occult Blood - Week 8: +1 |
|
| Urine Occult Blood - Week 8: +2 |
|
| Urine Occult Blood - Week 8: +3 |
|
| Urine Occult Blood - Week 12: Neg Value |
|
| Urine Occult Blood - Week 12: Trace |
|
| Urine Occult Blood - Week 12: +1 |
|
| Urine Occult Blood - Week 12: +2 |
|
| Urine Occult Blood - Week 12: +3 |
|
| Urine Occult Blood - Week 12/EW: Neg Value |
|
| Urine Occult Blood - Week 12/EW: Trace |
|
| Urine Occult Blood - Week 12/EW: +1 |
|
| Urine Occult Blood - Week 12/EW: +2 |
|
| Urine Occult Blood - Week 12/EW: +3 |
|
| Urine Occult Blood - Week 13: Neg Value |
|
| Urine Occult Blood - Week 13: Trace |
|
| Urine Occult Blood - Week 13: +1 |
|
| Urine Occult Blood - Week 13: +2 |
|
| Urine Occult Blood - Week 13: +3 |
|
| Urine Glucose - Baseline: Neg Value |
|
| Urine Glucose - Baseline: Trace |
|
| Urine Glucose - Baseline: +1 |
|
| Urine Glucose - Baseline: +2 |
|
| Urine Glucose - Baseline: +3 |
|
| Urine Glucose - Week 4: Neg Value |
|
| Urine Glucose - Week 4: Trace |
|
| Urine Glucose - Week 4: +1 |
|
| Urine Glucose - Week 4: +2 |
|
| Urine Glucose - Week 4: +3 |
|
| Urine Glucose - Week 8: Neg Value |
|
| Urine Glucose - Week 8: Trace |
|
| Urine Glucose - Week 8: +1 |
|
| Urine Glucose - Week 8: +2 |
|
| Urine Glucose - Week 8: +3 |
|
| Urine Glucose - Week 12: Neg Value |
|
| Urine Glucose - Week 12: Trace |
|
| Urine Glucose - Week 12: +1 |
|
| Urine Glucose - Week 12: +2 |
|
| Urine Glucose - Week 12: +3 |
|
| Urine Glucose - Week 12/EW: Neg Value |
|
| Urine Glucose - Week 12/EW: Trace |
|
| Urine Glucose - Week 12/EW: +1 |
|
| Urine Glucose - Week 12/EW: +2 |
|
| Urine Glucose - Week 12/EW: +3 |
|
| Urine Glucose - Week 13: Neg Value |
|
| Urine Glucose - Week 13: Trace |
|
| Urine Glucose - Week 13: +1 |
|
| Urine Glucose - Week 13: +2 |
|
| Urine Glucose - Week 13: +3 |
|
| Title | Measurements |
|---|---|
|
| Baseline: ANCS; Baseline: N |
|
| Baseline: ANCS; Baseline: ANCS |
|
| Baseline: ANCS; Baseline: ACS |
|
| Baseline: ACS; Baseline: N |
|
| Baseline; ACS; Baseline: ANCS |
|
| Baseline: ACS ; Baseline: ACS |
|
| Baseline: N; Week 4: N |
|
| Baseline: N; Week 4: ANCS |
|
| Baseline: N; Week 4: ACS |
|
| Baseline: ANCS; Week 4: N |
|
| Baseline: ANCS; Week 4: ANCS |
|
| Baseline: ANCS; Week 4: ACS |
|
| Baseline: ACS; Week 4: N |
|
| Baseline: ACS; Week 4: ANCS |
|
| Baseline: ACS; Week 4: ACS |
|
| Baseline: N; Week 8: N |
|
| Baseline: N; Week 8: ANCS |
|
| Baseline: N; Week 8: ACS |
|
| Baseline: ANCS; Week 8: N |
|
| Baseline: ANCS; Week 8: ANCS |
|
| Baseline: ANCS; Week 8: ACS |
|
| Baseline: ACS; Week 8: N |
|
| Baseline: ACS; Week 8: ANCS |
|
| Baseline: ACS; Week 8: ACS |
|
| Baseline: N; Week 12/EW: N |
|
| Baseline: N; Week 12/EW: ANCS |
|
| Baseline: N; Week 12/EW: ACS |
|
| Baseline: ANCS; Week 12/EW: N |
|
| Baseline: ANCS; Week 12/EW: ANCS |
|
| Baseline: ANCS; Week 12/EW: ACS |
|
| Baseline: ACS; Week 12/EW: N |
|
| Baseline: ACS; Week 12/EW: ANCS |
|
| Baseline: ACS; Week 12/EW: ACS |
|
| Baseline: N; Week 13: N |
|
| Baseline: N; Week 13: ANCS |
|
| Baseline: N; Week 13: ACS |
|
| Baseline: ANCS; Week 13: N |
|
| Baseline: ANCS; Week 13: ANCS |
|
| Baseline: ANCS; Week 13: ACS |
|
| Baseline: ACS; Week 13: N |
|
| Baseline: ACS; Week 13: ANCS |
|
| Baseline: ACS; Week 13: ACS |
|
| Title | Measurements |
|---|---|
|
| Semi-Supine Pulse Rate (bpm) |
|
| Standing Systolic BP (mmHg) |
|
| Standing Diastolic BP (mmHg) |
|
| Standing Pulse Rate (bpm) |
|
| Orthostatic Systolic BP (mmHg) |
|
| Orthostatic Diastolic BP (mmHg) |
|
| Orthostatic Pulse Rate (bpm) |
|
| Title | Measurements |
|---|---|
|
|
| Depression-HADS Depression Population -Baseline |
|
| Depression-HADS Depression Population-Week 12/EW |
|
| Change from Baseline for Depression Population |
|
|
| 2 subjects who received 3 mg of Study drug |
|
| 2 subjects who received 4 mg of Study drug |
|
|
| 2 subjects who received 3 mg of Study drug |
|
| 2 subjects who received 4 mg of Study drug |
|
|
| 2 subjects who received 3 mg of Study drug |
|
| 2 subjects who received 4 mg of Study drug |
|