Last updated: 11/04/2018 06:04:40
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 2 PoC in IBS patients with the CRF1 receptor anatgonist, GSK876008
Trial description: This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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).
Timeframe: 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).
Timeframe: 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
Timeframe: Up to Day 105
Mean Global Improvement Scale (GIS) Responder Rate over the last four weeks by regimen
Timeframe: 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
Timeframe: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Secondary outcomes:
Number of participants with improvements in pain and discomfort
Timeframe: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Change from Baseline in pain severity scores
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Interventions:
Drug: GW876008
Other: Placebo
Enrollment:
133
Observational study model:
Not applicable
Primary completion date:
2008-25-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Bowel Syndrome (IBS)
Product
emicerfont
Collaborators
Not applicable
Study date(s)
November 2006 to June 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- 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):
- 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
Inclusion and exclusion criteria
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).
Trial location(s)
Location
GSK Investigational Site
Austin, Texas, United States, 78705
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
Status
Study Complete
Location
GSK Investigational Site
Monroe, Louisiana, United States, 71201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Will Be Recruiting
Location
GSK Investigational Site
Sherwood, Arkansas, United States, 72120
Status
Will Be Recruiting
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Will Be Recruiting
Location
GSK Investigational Site
Tampa, Florida, United States, 33614
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27408
Status
Will Be Recruiting
Location
GSK Investigational Site
San Antonio, Texas, United States, 78209
Status
Will Be Recruiting
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Will Be Recruiting
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Will Be Recruiting
Location
GSK Investigational Site
Lynchburg, Virginia, United States, 24502
Status
Will Be Recruiting
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Will Be Recruiting
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Will Be Recruiting
Location
GSK Investigational Site
Concord, California, United States, 94520
Status
Will Be Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-25-06
Actual study completion date
2008-25-06
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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