Trial · NCT00421707
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
NCT00421707, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-12-26
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome. Trials, record NCT00421707. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00421707
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
- NCT number
- NCT00421707
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 133 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Irritable Bowel Syndrome (IBS)
- Interventions
- GW876008, Placebo
- First posted
- 2007-01-12
- Last updated
- 2018-01-31
- Results first posted
- 2017-12-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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). | 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. |
| 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). | 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. |
| 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 | 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. |
| Primary | 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. |
| Primary | 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 | 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'. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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). | Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2) | 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). | Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2). | Intent to Treat population. | ||
| 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 | Up to Day 105 | Intent to Treat population | ||
| PRIMARY | 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) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Proportion of participants responded | MEAN |
| PRIMARY | 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) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | 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) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Percentages of Pain-free Days | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | 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. | Percentage of days | MEAN |
| SECONDARY | 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) | Intent to Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | ng/mL | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group483
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | GW876008 125 mg | Pain and Discomfort | 0.26 | Standard Deviation 0.357 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Placebo | Pain and Discomfort | 0.22 | Standard Deviation 0.334 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | GW876008 125 mg | diarrhea | 0.30 | Standard Deviation 0.377 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Placebo | diarrhea | 0.28 | Standard Deviation 0.383 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | GW876008 125 mg | Constipation | 0.18 | Standard Deviation 0.319 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Placebo | Constipation | 0.16 | Standard Deviation 0.295 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | GW876008 125 mg | Stool Frequency | 0.25 | Standard Deviation 0.362 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Placebo | Stool Frequency | 0.24 | Standard Deviation 0.349 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | GW876008 125 mg | Stool Consistency | 0.24 | Standard Deviation 0.370 | Proportion of participants responded |
| Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Placebo | Stool Consistency | 0.21 | Standard Deviation 0.345 | Proportion of participants responded |
1 to 10 of 483Source ClinicalTrials.gov
See all 483 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Treatment Period 1 | STARTED | Sequence A/X/B | 67 | |
| Period 1: Treatment Period 1 | STARTED | Sequence B/X/A | 65 | |
| Period 1: Treatment Period 1 | COMPLETED | Sequence A/X/B | 56 | |
| Period 1: Treatment Period 1 | COMPLETED | Sequence B/X/A | 56 | |
| Period 1: Treatment Period 1 | NOT COMPLETED | Sequence A/X/B | 11 | |
| Period 1: Treatment Period 1 | NOT COMPLETED | Sequence B/X/A | 9 | |
| Period 2: Washout | STARTED | Sequence A/X/B | 56 | |
| Period 2: Washout | STARTED | Sequence B/X/A | 56 | |
| Period 2: Washout | COMPLETED | Sequence A/X/B | 55 | |
| Period 2: Washout | COMPLETED | Sequence B/X/A | 52 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | GW876008 125 mg | 9 | 119 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 120 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Washout | 2 | 112 | |
| serious | Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | GW876008 125 mg | 0 | 119 | |
| serious | Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 120 | |
| serious | Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo Washout | 0 | 112 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GW876008 125 mg | 0 | 119 |
| Total, all-cause mortality | Placebo | 0 | 120 |
| Total, all-cause mortality | Placebo Washout | 0 | 112 |
| Total, other adverse events | GW876008 125 mg | 9 | 119 |
| Total, other adverse events | Placebo | 5 | 120 |
| Total, other adverse events | Placebo Washout | 2 | 112 |
| Total, serious adverse events | GW876008 125 mg | 0 | 119 |
| Total, serious adverse events | Placebo | 1 | 120 |
| Total, serious adverse events | Placebo Washout | 0 | 112 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00421707
GET https://conductscience.org/api/trials/v1/NCT00421707/results?page=2