Clinical trial NCT00421707: Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Official title: A Phase 2 PoC in IBS Patients With the CRF1 Receptor Anatgonist, GSK876008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008


Eligibility 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).

Primary outcomes:
measure: 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)
measure: 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).
measure: 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
measure: 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)
measure: 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:
measure: 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)
measure: 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)
measure: Percentages of Pain-free Days
timeFrame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
measure: 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)
measure: 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
measure: IBS Composite Symptom Score
timeFrame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Sherwood
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Concord
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Monroe
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: