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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Drug: GW876008; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421707

CRI105626

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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133 participants in 2 patient groups, including a placebo group

GW876008

Experimental group

Description:

GW876008

Treatment:

Drug: GW876008

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

Drug: GW876008