Trial · NCT00385099
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
NCT00385099, Phase 2, Completed, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome. Trials, record NCT00385099. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00385099
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
- NCT number
- NCT00385099
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Irritable Colon
- Interventions
- GW876008
- First posted
- 2006-10-06
- Last updated
- 2017-08-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test) | Baseline (pre-dose) and Study Days 1, 2 and 3 | Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue. Participants were examined in the left lateral position where DRT4 laser Doppler flow meter was placed against the rectal mucosa 10 centimeter (cm) above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius. Physiological stress was evoked using the cold water pressor test. Participants were asked to place their hand and forearm into a container of ice-cold water at 0-4degree Celsius and were persuaded to maintain that position for as long as possible during the stress period of 10 minutes. Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value. |
| Primary | Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test) | Baseline (pre-dose) and Study Days 1, 2 and 3 | Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue, an indirect measure of flow can be obtained. Participants were examined in the left lateral position with no prior bowel preparation. The laser Doppler probe (DRT4 laser Doppler flow meter) was then placed against the rectal mucosa 10 centimeter above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius. The dichotomous listening test was used as a psychological stressor. At the onset of stress, folk music was played into one ear and rock music into the other ear for 10 minutes. Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value. |
| Secondary | Number of participants with adverse events (AE) and serious adverse events (SAE) | Up to Week 14 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. |
| Secondary | Number of participants with abnormal clinical chemistry data of clinical concern | Up to Week 14 | The clinical chemistry parameters included albumin, calcium low, creatinine, glucose, magnesium, phosphorus, potassium, sodium, and bicarbonate. The total number of participants with clinical chemistry data of clinical concern have been presented. |
| Secondary | Number of participants with abnormal hematology data of clinical concern | Up to Week 14 | The hematology parameters included white blood cell count, neutrophil count, hemoglobin, hematocrit, platelet count and lymphocytes. The total number of participants with hematology of clinical concern have been presented. |
| Secondary | Participant perceived stress as assessed by a Visual Analogue Scale | Study Days 1, 2 and 3 | The acute emotional response to stress during each study visit was assessed using a 10 cm description-anchored visual analogue scale, ranging from 0 to 10, where 0=no-stress and 10=Most stressed ever. Higher scores indicated significant stress. Participants were asked to mark this before onset of stress, after 10 minutes of stress and finally after 10 minutes of recovery. After the pre-stress recordings, the period of either physiological or psychological stress were commenced and continued for 10 minutes, followed by a period of recovery for a further 10 minutes. |
| Secondary | Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP) | Up to Week 14 | As an indicator of change in systemic autonomic activity, blood pressure was measured pre-stress, after 10 minutes of stress and after 10 minutes of recovery using a Dinamap. |
| Secondary | Systemic autonomic nervous system response as assessed by heart rate (HR). | Up to Week 14 | As an indicator of change in systemic autonomic activity, HR was measured pre-stress, after 10 minutes of stress and after 10 minutes of recovery using a Dinamap. |
| Secondary | Percent change from Baseline in participant reported threshold for pain as a measure to assess Visceral (rectal) electro sensitivity | Baseline (pre-dose) and Study Days 1, 2 and 3 | Visceral (rectal) sensitivity to pain was measured using previously validated techniques. In brief, a 1-cm bipolar electrode (21L10) mounted on a 14-gauge Foley catheter was placed initially into the anal canal before the period of acclimatization. The stimulation parameters were set at 0.5-millisecond pulse width and 10-Hertz frequency for rectal measurements. The current was then increased slowly and the participants were asked to report when they felt it was painful (pain). Rectal measurements were made 8 cm above the anal verge. Measurements were made pre-stress, after 10 minutes of stress, and then after 10 minutes of recovery. The catheter remained in situ throughout the study but was moved from anal to rectal sites for the 2 measurements. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value. |
| Secondary | Percent change from Baseline in participant reported threshold for perception of an electrical stimulus as a measure to assess Visceral (rectal) electro sensitivity | Study Days 1, 2 and 3 | Visceral (rectal) sensitivity to perception was measured using previously validated techniques. In brief, a 1-cm bipolar electrode (21L10) mounted on a 14-gauge Foley catheter was placed initially into the anal canal before the period of acclimatization. The stimulation parameters were set at 0.5-millisecond pulse width and 10-Hertz frequency for rectal measurements. The current was then increased slowly and the participants will be asked to report when they were first aware of this (perception). Rectal measurements were made 8 centimeter above the anal verge. Measurements were made pre-stress, after 10 minutes of stress, and then after 10 minutes of recovery. The catheter remained in situ throughout the study but will be moved from anal to rectal sites for the 2 measurements. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
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