Phase 2
Completed N=132
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT00421707 ↗Enrolled (actual)
132
Serious AEs
0.3%
Results posted
Dec 2017
Primary outcomePrimary: 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).
Summary
This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
— | — |
| PRIMARY 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). |
— | — |
| PRIMARY 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 |
— | — |
| PRIMARY Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen |
0.26; 0.22; 0.30; 0.28; 0.18; 0.16 | — |
| PRIMARY Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale |
15.35; 15.72; 15.39; 21.07; 21.39; 21.21 | — |
| SECONDARY Number of Participants With Improvements in Pain and Discomfort |
25; 20; 24; 92; 95; 85 | — |
| SECONDARY Change From Baseline in Pain Severity Scores |
-0.04; 0.03; -0.25; -0.35; -0.89; -0.87 | — |
| SECONDARY Percentages of Pain-free Days |
27.25; 24.38; 34.92; 32.72; 28.21; 32.82 | — |
| SECONDARY Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function |
28; 28; 33; 89; 87; 76 | — |
| SECONDARY Plasma Concentrations of GW876008 at Week 3 and 6 |
672.691; NA; 1312.573; 1170.096; 966.653; 696.690 | — |
| SECONDARY IBS Composite Symptom Score |
— | — |
| SECONDARY Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment |
8.6; 8.5; 8.5; 8.8; 8.5 | — |
| SECONDARY Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) |
4.84; 4.68; 4.61; 4.98; 4.56; 2.68 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00421707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.