Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Irritable Bowel Syndrome safety
Brief summary
This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
Interventions
DRUGGW876008
OTHERPlacebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol * The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization): If the subject is \< 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed. If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed. * Colonic procedure results must be known prior to randomization into the study and dispensing study medication * During the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment using the telephone data entry system
Exclusion criteria
* As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician * Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study * The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2). | Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2) | For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study. |
| Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2). | Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2). | For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study. |
| Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2 | Up to Day 105 | For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study. |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder. |
| Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBS Composite Symptom Score | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score. |
| Number of Participants With Improvements in Pain and Discomfort | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Number of participants with improvements in pain and discomfort on GIS were presented. GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse on specified time points. Responder = Yes if A responder answered either 'moderately improved' or 'substantially improved'. |
| Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | HAD Scale was used to assess the severity of symptoms of anxiety and depression in participants. There were 14 questions. Seven questions related to depression and seven questions related to anxiety. Participants rated the severity of symptoms in the answer to each question. There were four options in each answer, from which participants had to select one. Responses were scored on a scale of 0, 1, 2 or 3, where 0 indicated best and 3 indicated worse. Total score ranged from 0-42 where 0 indicated absence of symptoms and higher scores indicated higher anxiety/depression complains. This questionnaire was completed at screening, and all study visits. |
| Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | The PHQ-15 comprised of 15 somatic symptoms from the PHQ, each symptom scored from 0 to 2, where 0 (Not bothered at all), 1 (Bothered a little) 2 (bothered a lot). This questionnaire was completed at screening, and all study visits. Total score range was 0-30, where 0 indicated Not bothered at all and 30 indicated bothered a lot. Higher score indicated greater severity of somatization symptoms. |
| Change From Baseline in Pain Severity Scores | Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Pain severity scores from the 11-point scale and it's corresponding change from Baseline scores was summarized by treatment group for the last 4 weeks (i.e. weeks 3-6 and Weeks 12-15) of treatment period. Scale from 0 to 10, 0 meaning no pain, 10 worst possible pain. Lower values represent a better outcome. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting baseline value from specified time point value. Reported data values are lesser than minimum score on scale as change from Baseline is reported. |
| Percentages of Pain-free Days | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Abdominal pain free days are those days where the participant reported a score of '0' for abdominal pain at its worst. Abdominal Pain (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain. |
| Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | The GIS comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. Number of participants who showed improvement and changes on the scale were presented. Participants were counted as Yes if they scored 1-3, and as No if they scored 4-7. |
| Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement | For Week 3, 6, 9, 12, and 15 visits blood samples were collected at: pre-dose (after the pre ECG measurement and just before am dose) and immediately following the 1-3 hour post-dose ECG measurement and concentration of GW876008 was analyzed. Data for Week 3 and 6 was presented. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 132 participants with irritable bowel syndrome (IBS), as classified by the Rome II criteria for IBS, but otherwise healthy, were randomized in this study. Study was conducted at 20 centers (14 centers in united states, six centers in Canada) from 14 October 2006 to 25 June 2008
Participants by arm
| Arm | Count |
|---|---|
| Sequence A/X/B As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks, followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received matching placebo (B) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose pharmacokinetic (PK) blood sample. | 67 |
| Sequence B/X/A As per the treatment sequence B/X/A, during period 1, eligible participants received matching placebo (B) once daily for 6 weeks followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample. | 65 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Treatment Period 1 | Adverse Event | 7 | 2 |
| Period 1: Treatment Period 1 | Lost to Follow-up | 2 | 2 |
| Period 1: Treatment Period 1 | Protocol Violation | 1 | 0 |
| Period 1: Treatment Period 1 | Withdrawal by Subject | 1 | 5 |
| Period 2: Washout | Adverse Event | 1 | 1 |
| Period 2: Washout | Lost to Follow-up | 0 | 1 |
| Period 2: Washout | Other: Pregnancy | 0 | 1 |
| Period 2: Washout | Withdrawal by Subject | 0 | 1 |
| Period 3:Treatment Period 2 | Adverse Event | 0 | 2 |
| Period 3:Treatment Period 2 | Protocol Violation | 1 | 0 |
| Period 3:Treatment Period 2 | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Sequence B/X/A | Total | Sequence A/X/B |
|---|---|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 11.43 | 43.5 Years STANDARD_DEVIATION 11.56 | 44.1 Years STANDARD_DEVIATION 11.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 110 Participants | 58 Participants |
| Sex: Female, Male Female | 48 Participants | 100 Participants | 52 Participants |
| Sex: Female, Male Male | 17 Participants | 32 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 120 | 0 / 112 |
| other Total, other adverse events | 9 / 119 | 5 / 120 | 2 / 112 |
| serious Total, serious adverse events | 0 / 119 | 1 / 120 | 0 / 112 |
Outcome results
Primary
Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen
The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Urgency | 0.24 Proportion of participants responded | Standard Deviation 0.365 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | diarrhea | 0.30 Proportion of participants responded | Standard Deviation 0.377 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Bloating | 0.18 Proportion of participants responded | Standard Deviation 0.329 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Constipation | 0.18 Proportion of participants responded | Standard Deviation 0.319 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Incomplete Evacuation | 0.19 Proportion of participants responded | Standard Deviation 0.35 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Pain and Discomfort | 0.26 Proportion of participants responded | Standard Deviation 0.357 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Straining | 0.19 Proportion of participants responded | Standard Deviation 0.341 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Stool Frequency | 0.25 Proportion of participants responded | Standard Deviation 0.362 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | IBS Symptoms | 0.32 Proportion of participants responded | Standard Deviation 0.403 |
| GW876008 125 mg | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Stool Consistency | 0.24 Proportion of participants responded | Standard Deviation 0.37 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | IBS Symptoms | 0.26 Proportion of participants responded | Standard Deviation 0.357 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Stool Frequency | 0.24 Proportion of participants responded | Standard Deviation 0.349 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Pain and Discomfort | 0.22 Proportion of participants responded | Standard Deviation 0.334 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Constipation | 0.16 Proportion of participants responded | Standard Deviation 0.295 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Stool Consistency | 0.21 Proportion of participants responded | Standard Deviation 0.345 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Urgency | 0.25 Proportion of participants responded | Standard Deviation 0.363 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Bloating | 0.16 Proportion of participants responded | Standard Deviation 0.287 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Incomplete Evacuation | 0.16 Proportion of participants responded | Standard Deviation 0.307 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Straining | 0.19 Proportion of participants responded | Standard Deviation 0.319 |
| Placebo | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | diarrhea | 0.28 Proportion of participants responded | Standard Deviation 0.383 |
Primary
Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Time frame: Up to Day 105
Population: Intent to Treat population
Primary
Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Time frame: Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population comprised of all participants who were randomized to treatment, who received at least one dose of double blind medication and for whom at least one valid post baseline efficacy assessment was available.
Primary
Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).
For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Time frame: Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).
Population: Intent to Treat population.
Primary
Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale
The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Social | 16.11 Score on a scale | Standard Deviation 3.783 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Emotional | 15.35 Score on a scale | Standard Deviation 3.852 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Energy | 8.22 Score on a scale | Standard Deviation 1.892 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sexual Relations | 12.30 Score on a scale | Standard Deviation 3.122 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Physical Functioning | 5.23 Score on a scale | Standard Deviation 1.683 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Role-Physical | 15.16 Score on a scale | Standard Deviation 4.472 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Mental Health | 21.07 Score on a scale | Standard Deviation 4.141 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Food/Diet | 14.27 Score on a scale | Standard Deviation 3.131 |
| GW876008 125 mg | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sleep | 12.49 Score on a scale | Standard Deviation 2.489 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Food/Diet | 14.74 Score on a scale | Standard Deviation 2.894 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Social | 16.39 Score on a scale | Standard Deviation 3.414 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Emotional | 15.72 Score on a scale | Standard Deviation 3.674 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Role-Physical | 15.85 Score on a scale | Standard Deviation 4.189 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sexual Relations | 13.10 Score on a scale | Standard Deviation 2.667 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sleep | 12.47 Score on a scale | Standard Deviation 2.57 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Energy | 8.25 Score on a scale | Standard Deviation 1.986 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Physical Functioning | 5.63 Score on a scale | Standard Deviation 2.282 |
| Placebo | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Mental Health | 21.39 Score on a scale | Standard Deviation 3.116 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sexual Relations | 12.73 Score on a scale | Standard Deviation 3.056 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Role-Physical | 15.44 Score on a scale | Standard Deviation 4.261 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Emotional | 15.39 Score on a scale | Standard Deviation 3.595 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Mental Health | 21.21 Score on a scale | Standard Deviation 3.253 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Sleep | 12.79 Score on a scale | Standard Deviation 2.551 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Physical Functioning | 5.50 Score on a scale | Standard Deviation 2.067 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Food/Diet | 14.60 Score on a scale | Standard Deviation 2.89 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Social | 16.43 Score on a scale | Standard Deviation 3.767 |
| Placebo Washout | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Energy | 8.21 Score on a scale | Standard Deviation 1.87 |
Secondary
Change From Baseline in Pain Severity Scores
Pain severity scores from the 11-point scale and it's corresponding change from Baseline scores was summarized by treatment group for the last 4 weeks (i.e. weeks 3-6 and Weeks 12-15) of treatment period. Scale from 0 to 10, 0 meaning no pain, 10 worst possible pain. Lower values represent a better outcome. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting baseline value from specified time point value. Reported data values are lesser than minimum score on scale as change from Baseline is reported.
Time frame: Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Feeling full severity, Week 3-6 | -0.54 Score on a scale | Standard Deviation 0.729 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Stool frequency, Week 3-6 | -0.25 Score on a scale | Standard Deviation 0.905 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Feeling excessively full severity, Week 3-6 | -0.48 Score on a scale | Standard Deviation 0.726 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Urgency severity, Week 3-6 | -0.58 Score on a scale | Standard Deviation 0.605 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Bloating severity, Week 3-6 | -0.78 Score on a scale | Standard Deviation 0.798 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | IBS Symptoms, Week 3-6 | -0.58 Score on a scale | Standard Deviation 0.501 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Diarrhoea severity, Week 3-6 | -0.43 Score on a scale | Standard Deviation 0.619 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | 5 point pain severity, Week 3-6 | -0.89 Score on a scale | Standard Deviation 0.745 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Constipation severity, Week 3-6 | -0.31 Score on a scale | Standard Deviation 0.592 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Nausea severity, Week 3-6 | -0.27 Score on a scale | Standard Deviation 0.546 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Flatulence severity, Week 3-6 | -0.54 Score on a scale | Standard Deviation 0.632 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Straining severity, Week 3-6 | -0.31 Score on a scale | Standard Deviation 0.568 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Vomitting severity, Week 3-6 | -0.00 Score on a scale | Standard Deviation 0.072 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Incomplete evacuation severity, Week 3-6 | -0.47 Score on a scale | Standard Deviation 0.704 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Stool consistency, Week 3-6 | -0.04 Score on a scale | Standard Deviation 0.654 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Heartburn severity, Week 3-6 | -0.18 Score on a scale | Standard Deviation 0.617 |
| GW876008 125 mg | Change From Baseline in Pain Severity Scores | Burping severity, Week 3-6 | -0.36 Score on a scale | Standard Deviation 0.568 |
| Placebo | Change From Baseline in Pain Severity Scores | Heartburn severity, Week 3-6 | -0.17 Score on a scale | Standard Deviation 0.544 |
| Placebo | Change From Baseline in Pain Severity Scores | Incomplete evacuation severity, Week 3-6 | -0.48 Score on a scale | Standard Deviation 0.587 |
| Placebo | Change From Baseline in Pain Severity Scores | Stool consistency, Week 3-6 | 0.03 Score on a scale | Standard Deviation 0.571 |
| Placebo | Change From Baseline in Pain Severity Scores | 5 point pain severity, Week 3-6 | -0.87 Score on a scale | Standard Deviation 0.753 |
| Placebo | Change From Baseline in Pain Severity Scores | IBS Symptoms, Week 3-6 | -0.55 Score on a scale | Standard Deviation 0.498 |
| Placebo | Change From Baseline in Pain Severity Scores | Nausea severity, Week 3-6 | -0.31 Score on a scale | Standard Deviation 0.525 |
| Placebo | Change From Baseline in Pain Severity Scores | Vomitting severity, Week 3-6 | -0.02 Score on a scale | Standard Deviation 0.129 |
| Placebo | Change From Baseline in Pain Severity Scores | Burping severity, Week 3-6 | -0.35 Score on a scale | Standard Deviation 0.599 |
| Placebo | Change From Baseline in Pain Severity Scores | Feeling full severity, Week 3-6 | -0.49 Score on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Pain Severity Scores | Feeling excessively full severity, Week 3-6 | -0.48 Score on a scale | Standard Deviation 0.671 |
| Placebo | Change From Baseline in Pain Severity Scores | Bloating severity, Week 3-6 | -0.77 Score on a scale | Standard Deviation 0.684 |
| Placebo | Change From Baseline in Pain Severity Scores | Diarrhoea severity, Week 3-6 | -0.42 Score on a scale | Standard Deviation 0.573 |
| Placebo | Change From Baseline in Pain Severity Scores | Constipation severity, Week 3-6 | -0.33 Score on a scale | Standard Deviation 0.546 |
| Placebo | Change From Baseline in Pain Severity Scores | Urgency severity, Week 3-6 | -0.45 Score on a scale | Standard Deviation 0.617 |
| Placebo | Change From Baseline in Pain Severity Scores | Straining severity, Week 3-6 | -0.34 Score on a scale | Standard Deviation 0.556 |
| Placebo | Change From Baseline in Pain Severity Scores | Flatulence severity, Week 3-6 | -0.50 Score on a scale | Standard Deviation 0.593 |
| Placebo | Change From Baseline in Pain Severity Scores | Stool frequency, Week 3-6 | -0.35 Score on a scale | Standard Deviation 0.932 |
Secondary
Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment
The PHQ-15 comprised of 15 somatic symptoms from the PHQ, each symptom scored from 0 to 2, where 0 (Not bothered at all), 1 (Bothered a little) 2 (bothered a lot). This questionnaire was completed at screening, and all study visits. Total score range was 0-30, where 0 indicated Not bothered at all and 30 indicated bothered a lot. Higher score indicated greater severity of somatization symptoms.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Week 3 | 8.6 Score on a scale | Standard Deviation 4.42 |
| GW876008 125 mg | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Week 6 | 8.8 Score on a scale | Standard Deviation 4.99 |
| Placebo | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Week 3 | 8.5 Score on a scale | Standard Deviation 3.89 |
| Placebo | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Week 6 | 8.5 Score on a scale | Standard Deviation 4.03 |
| Placebo Washout | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Week 3 | 8.5 Score on a scale | Standard Deviation 4.02 |
Secondary
IBS Composite Symptom Score
Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Secondary
Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function
The GIS comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. Number of participants who showed improvement and changes on the scale were presented. Participants were counted as Yes if they scored 1-3, and as No if they scored 4-7.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, Yes | 35 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, No | 97 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, No | 89 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, Yes | 20 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, Yes | 24 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 2, No | 87 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, No | 94 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, Yes | 23 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, No | 98 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, No | 80 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, No | 101 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, Yes | 24 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, No | 93 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, Yes | 27 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, Yes | 32 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, Yes | 16 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, No | 90 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, Yes | 37 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, No | 94 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, Yes | 26 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, No | 80 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, Yes | 23 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, No | 91 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, Yes | 41 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, Yes | 24 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea,Week 2,Yes | 30 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, No | 93 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, Yes | 37 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, Yes | 30 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, No | 76 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, No | 94 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, No | 87 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, Yes | 23 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, Yes | 28 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, No | 75 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, No | 98 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, No | 89 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,Yes | 33 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, Yes | 19 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, Yes | 27 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, Yes | 34 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, No | 95 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, No | 90 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, Yes | 42 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, Yes | 22 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, Yes | 29 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,No | 84 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, No | 98 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, No | 88 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, Yes | 27 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, Yes | 19 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, No | 88 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1, Yes | 15 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, Yes | 29 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1 ,No | 102 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, No | 85 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, Yes | 18 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, No | 89 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, No | 99 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, No | 90 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, No | 92 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, Yes | 19 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, Yes | 28 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, Yes | 25 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, No | 98 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, Yes | 26 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, No | 95 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, No | 83 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, Yes | 22 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, No | 76 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, Yes | 19 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, Yes | 22 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, No | 91 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, No | 95 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, Yes | 31 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, Yes | 23 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, Yes | 30 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, No | 94 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, Yes | 34 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, Yes | 41 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, No | 93 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, No | 87 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, Yes | 24 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, No | 83 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, No | 82 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, Yes | 28 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, No | 93 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, No | 93 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, Yes | 24 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, No | 86 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, No | 96 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, Yes | 17 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, No | 100 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, Yes | 21 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, No | 86 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, Yes | 30 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, No | 87 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, Yes | 27 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, No | 90 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, Yes | 23 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, Yes | 27 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, No | 90 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, Yes | 27 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, Yes | 23 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, Yes | 17 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, No | 98 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, Yes | 36 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, No | 81 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,Yes | 29 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,No | 88 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1 ,No | 101 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, Yes | 15 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, No | 101 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, Yes | 15 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, No | 103 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, Yes | 18 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, No | 99 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, Yes | 19 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1, Yes | 14 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, No | 93 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, Yes | 18 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, No | 95 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, No | 90 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, No | 94 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, No | 95 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, Yes | 23 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, Yes | 25 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, No | 93 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, Yes | 29 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, No | 88 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, Yes | 26 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, No | 90 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, Yes | 31 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, No | 87 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, Yes | 28 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, No | 89 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, Yes | 29 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, No | 88 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, Yes | 28 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, No | 89 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, Yes | 14 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, No | 101 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, Yes | 14 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, No | 102 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, Yes | 19 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, No | 99 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, Yes | 15 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, No | 102 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, Yes | 10 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, No | 105 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, Yes | 14 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, No | 102 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, Yes | 18 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, No | 100 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, Yes | 18 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, No | 99 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, No | 97 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, Yes | 8 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, No | 107 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, Yes | 17 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, No | 99 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, Yes | 23 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, Yes | 21 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, Yes | 22 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, No | 95 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, Yes | 21 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, Yes | 22 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, No | 93 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, Yes | 22 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, No | 94 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, Yes | 30 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, No | 88 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, Yes | 33 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, No | 84 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, Yes | 30 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, No | 87 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, Yes | 29 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, No | 88 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, Yes | 28 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, No | 87 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea,Week 2,Yes | 30 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 2, No | 86 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, Yes | 33 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, No | 85 Participants |
| Placebo | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, Yes | 31 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, Yes | 22 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, Yes | 22 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, No | 88 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 2, Yes | 24 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, No | 87 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 2, No | 80 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 1, Yes | 22 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, Yes | 14 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 1, No | 95 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, Yes | 19 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 2, No | 93 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, Yes | 21 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 3, No | 91 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, No | 95 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, Yes | 29 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 3, Yes | 17 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, No | 93 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, No | 89 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 2, Yes | 19 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1 ,No | 93 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, Yes | 33 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Straining, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Constipation, Week 1, Yes | 16 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 3, Yes | 23 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, Yes | 30 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, Yes | 17 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 3, No | 83 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 1, No | 92 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 1, No | 79 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, Yes | 18 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 6,Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 2, No | 94 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 1, No | 76 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, Yes | 19 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, Yes | 30 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 3, No | 93 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, No | 88 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 3, Yes | 24 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, No | 87 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, No | 85 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 2, No | 82 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 2, Yes | 27 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, No | 91 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, Yes | 29 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Bloating, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool frequency, Week 3, Yes | 21 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, Yes | 17 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Diarrhea,Week 2,Yes | 32 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 1, No | 92 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 3, No | 83 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, Yes | 24 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Sense of urgency, Week 1, No | 87 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 2, No | 88 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 1, Yes | 22 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, Yes | 21 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Stool consistency, Week 2, No | 90 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | IBS symptoms, Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Incomplete evacuation, Week 3, No | 91 Participants |
Secondary
Number of Participants With Improvements in Pain and Discomfort
Number of participants with improvements in pain and discomfort on GIS were presented. GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse on specified time points. Responder = Yes if A responder answered either 'moderately improved' or 'substantially improved'.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 6, Yes | 31 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 2, No | 92 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 5, No | 86 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 3, Yes | 30 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 3, No | 87 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 5, Yes | 31 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 1, No | 92 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 4, Yes | 30 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 6, No | 86 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 2, Yes | 25 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 4, No | 87 Participants |
| GW876008 125 mg | Number of Participants With Improvements in Pain and Discomfort | Week 1, Yes | 25 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 4, No | 91 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 5, Yes | 28 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 5, No | 89 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 6, Yes | 26 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 2, Yes | 18 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 6, No | 91 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 1, Yes | 20 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 3, Yes | 22 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 3, No | 96 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 4, Yes | 26 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 1, No | 95 Participants |
| Placebo | Number of Participants With Improvements in Pain and Discomfort | Week 2, No | 98 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 6, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 2, No | 88 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 5, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 1, Yes | 24 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 1, No | 85 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 2, Yes | 24 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 3, Yes | 31 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 3, No | 81 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 4, Yes | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 4, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 5, No | 0 Participants |
| Placebo Washout | Number of Participants With Improvements in Pain and Discomfort | Week 6, Yes | 0 Participants |
Secondary
Percentages of Pain-free Days
Abdominal pain free days are those days where the participant reported a score of '0' for abdominal pain at its worst. Abdominal Pain (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Percentages of Pain-free Days | Week 3 | 38.14 Percentage of days | Standard Deviation 38.113 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 3-6 | 36.87 Percentage of days | Standard Deviation 35.47 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 5 | 36.04 Percentage of days | Standard Deviation 38.277 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 4 | 35.52 Percentage of days | Standard Deviation 36.075 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 2 | 32.72 Percentage of days | Standard Deviation 37.331 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 1 | 27.25 Percentage of days | Standard Deviation 33.261 |
| GW876008 125 mg | Percentages of Pain-free Days | Week 6 | 39.97 Percentage of days | Standard Deviation 42.315 |
| Placebo | Percentages of Pain-free Days | Week 3 | 32.45 Percentage of days | Standard Deviation 36.87 |
| Placebo | Percentages of Pain-free Days | Week 1 | 24.38 Percentage of days | Standard Deviation 31.015 |
| Placebo | Percentages of Pain-free Days | Week 2 | 28.21 Percentage of days | Standard Deviation 34.768 |
| Placebo | Percentages of Pain-free Days | Week 3-6 | 33.31 Percentage of days | Standard Deviation 32.875 |
| Placebo | Percentages of Pain-free Days | Week 4 | 33.09 Percentage of days | Standard Deviation 38.059 |
| Placebo | Percentages of Pain-free Days | Week 5 | 32.30 Percentage of days | Standard Deviation 35.303 |
| Placebo | Percentages of Pain-free Days | Week 6 | 34.29 Percentage of days | Standard Deviation 37.358 |
| Placebo Washout | Percentages of Pain-free Days | Week 2 | 32.82 Percentage of days | Standard Deviation 36.528 |
| Placebo Washout | Percentages of Pain-free Days | Week 3 | 35.14 Percentage of days | Standard Deviation 37.688 |
| Placebo Washout | Percentages of Pain-free Days | Week 1 | 34.92 Percentage of days | Standard Deviation 37.032 |
Secondary
Plasma Concentrations of GW876008 at Week 3 and 6
For Week 3, 6, 9, 12, and 15 visits blood samples were collected at: pre-dose (after the pre ECG measurement and just before am dose) and immediately following the 1-3 hour post-dose ECG measurement and concentration of GW876008 was analyzed. Data for Week 3 and 6 was presented.
Time frame: Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement
Population: Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed was included. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, 3 to < 4 HR | 966.653 ng/mL | Standard Deviation 528.019 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, pre dose | 672.691 ng/mL | Standard Deviation 538.6495 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, < 1 HR | NA ng/mL | — |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, 1 to < 2 HR | 1312.573 ng/mL | Standard Deviation 716.2118 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, 2 to < 3 HR | 1170.096 ng/mL | Standard Deviation 873.3578 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3, >= 4 HR | 696.690 ng/mL | — |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 6, pre dose | 625.645 ng/mL | Standard Deviation 493.5978 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 6, < 1 HR | 850.028 ng/mL | Standard Deviation 680.8931 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 6, 1 to < 2 HR | 1082.773 ng/mL | Standard Deviation 656.4102 |
| GW876008 125 mg | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 6, 2 to < 3 HR | 1004.535 ng/mL | Standard Deviation 642.882 |
Secondary
Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD)
HAD Scale was used to assess the severity of symptoms of anxiety and depression in participants. There were 14 questions. Seven questions related to depression and seven questions related to anxiety. Participants rated the severity of symptoms in the answer to each question. There were four options in each answer, from which participants had to select one. Responses were scored on a scale of 0, 1, 2 or 3, where 0 indicated best and 3 indicated worse. Total score ranged from 0-42 where 0 indicated absence of symptoms and higher scores indicated higher anxiety/depression complains. This questionnaire was completed at screening, and all study visits.
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Population: Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW876008 125 mg | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Anxiety, Week 3 | 4.84 Score on a scale | Standard Deviation 3.69 |
| GW876008 125 mg | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Anxiety, Week 6 | 4.98 Score on a scale | Standard Deviation 4.141 |
| GW876008 125 mg | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Depression, Week 3 | 2.68 Score on a scale | Standard Deviation 3.027 |
| GW876008 125 mg | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Depression, Week 6 | 3.11 Score on a scale | Standard Deviation 3.612 |
| Placebo | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Anxiety, Week 6 | 4.56 Score on a scale | Standard Deviation 3.63 |
| Placebo | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Depression, Week 6 | 2.50 Score on a scale | Standard Deviation 2.723 |
| Placebo | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Depression, Week 3 | 2.79 Score on a scale | Standard Deviation 3.458 |
| Placebo | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Anxiety, Week 3 | 4.68 Score on a scale | Standard Deviation 3.845 |
| Placebo Washout | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Anxiety, Week 3 | 4.61 Score on a scale | Standard Deviation 3.749 |
| Placebo Washout | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Depression, Week 3 | 2.86 Score on a scale | Standard Deviation 3.297 |