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This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW876008 | Experimental | GW876008 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW876008 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2). |
| 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. | Up to Day 105 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sherwood | Arkansas | 72120 | United States | ||
| GSK Investigational Site |
Not provided
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A/X/B | As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 milligram (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period 1 |
|
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|
| Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (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) |
| 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. | Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | 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 |
| IBS Composite Symptom Score | Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score. | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| 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. | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| Concord |
| California |
| 94520 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Monroe | Louisiana | 71201 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27408 | United States |
| GSK Investigational Site | Anderson | South Carolina | 29621 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| GSK Investigational Site | Germantown | Tennessee | 38138 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | San Antonio | Texas | 78209 | United States |
| GSK Investigational Site | Lynchburg | Virginia | 24502 | United States |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3J 1N2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3N 2V7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 1J5 | Canada |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Washout |
|
|
| Period 3:Treatment Period 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2) |
|
| |||||||||||||||||||||||||
| 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. | Intent to Treat population. | Posted | Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2). |
| ||||||||||||||||||||||||||
| 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. | Intent to Treat population | Posted | Up to Day 105 |
| ||||||||||||||||||||||||||
| 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. | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of participants responded | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| |||||||||||||||||||||||
| 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. | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| |||||||||||||||||||||||
| 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'. | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| ||||||||||||||||||||||||
| 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. | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| |||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of days | 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. | Intent to Treat population. | Posted | Count of Participants | Participants | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| ||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||
| Secondary | IBS Composite Symptom Score | Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score. | Posted | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| |||||||||||||||||||||||||||
| 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. | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
| |||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) |
|
Up to Day 147
Safety population was used for AE,SAE and nSAE collection.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GW876008 125 mg | Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. | 0 | 119 | 0 | 119 | 9 | 119 |
| EG001 | Placebo | Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. | 0 | 120 | 1 | 120 | 5 | 120 |
| EG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. | 0 | 112 | 0 | 112 | 2 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552097 | GW 876008 |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Other: Pregnancy |
|
| Adverse Event |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
|
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
|
Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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.
|
|
| Placebo |
Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
|
|
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
|
|
|
|
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
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| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
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| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
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| Placebo |
Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
| OG002 | Placebo Washout | Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg 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. |
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