Last updated: 11/04/2018 06:04:23
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
GSK study ID
CRI103143
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase IIa pharmacodynamic study of antagonism of irritable bowel syndrome (IBS) symptoms by GW876008, a corticotrophin releasing factor 1 receptor antagonist (CRF1-RA)
Trial description: The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)
Timeframe: Baseline (pre-dose) and Study Days 1, 2 and 3
Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test)
Timeframe: Baseline (pre-dose) and Study Days 1, 2 and 3
Secondary outcomes:
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to Week 14
Number of participants with abnormal clinical chemistry data of clinical concern
Timeframe: Up to Week 14
Number of participants with abnormal hematology data of clinical concern
Timeframe: Up to Week 14
Participant perceived stress as assessed by a Visual Analogue Scale
Timeframe: Study Days 1, 2 and 3
Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP)
Timeframe: Up to Week 14
Systemic autonomic nervous system response as assessed by heart rate (HR).
Timeframe: Up to Week 14
Percent change from Baseline in participant reported threshold for pain as a measure to assess Visceral (rectal) electro sensitivity
Timeframe: Baseline (pre-dose) and Study Days 1, 2 and 3
Percent change from Baseline in participant reported threshold for perception of an electrical stimulus as a measure to assess Visceral (rectal) electro sensitivity
Timeframe: Study Days 1, 2 and 3
Change from Baseline in RMBF at 90 minutes post-dose
Timeframe: Baseline (pre-dose) and Study Days 1, 2 and 3
Interventions:
Drug: GW876008
Enrollment:
9
Observational study model:
Not applicable
Primary completion date:
2007-15-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Colon
Product
emicerfont
Collaborators
Not applicable
Study date(s)
December 2006 to October 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Must have irritable bowel syndrome.
- Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Must have irritable bowel syndrome.
Exclusion criteria:
- Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-15-10
Actual study completion date
2007-15-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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