Last updated: 11/04/2018 06:04:40

Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome

GSK study ID
CRI105626
See study documents
Clinicaltrials.gov ID
NCT00421707
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-25-06
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78705
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Saskatoon, Saskatchewan, Canada, S7K 1J5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Monroe, Louisiana, United States, 71201
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Stockbridge, Georgia, United States, 30281
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M3J 1N2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M3H 5S4
    Status
    Study Complete
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    Showing 1 - 6 of 23 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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