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

NCT00421707 | Completed Phase 2 Results

• 1 other identifier: CRI105626
• Study Type: interventional
• Target: 133
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome safety

Outcome Measures

Primary Outcomes (5)

• 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).

  For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

  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).

  For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

  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

  For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

  Up to Day 105

• Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen

  The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.

  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

  The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.

  Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

Secondary Outcomes (8)

• Number of Participants With Improvements in Pain and Discomfort

  Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

• Change From Baseline in Pain Severity Scores

  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

  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

  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

  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

Study Arms (2)

GW876008

EXPERIMENTAL

GW876008

Drug: GW876008

Placebo

PLACEBO COMPARATOR

Placebo

Drug: GW876008; Other: Placebo

Interventions

GW876008 DRUG

GW876008; Placebo

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (23)

GSK Investigational Site

Sherwood, Arkansas, 72120, United States

Location

GSK Investigational Site

Concord, California, 94520, United States

Location

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Monroe, Louisiana, 71201, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, United States

Location

GSK Investigational Site

Anderson, South Carolina, 29621, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

GSK Investigational Site

Germantown, Tennessee, 38138, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

GSK Investigational Site

Lynchburg, Virginia, 24502, United States

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3H 5S4, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3J 1N2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3N 2V7, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Saskatoon, Saskatchewan, S7K 1J5, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

GW 876008

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 12, 2007
• Study Start: October 14, 2006
• Primary Completion: June 25, 2008
• Study Completion: June 25, 2008
• Last Updated: January 31, 2018
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Locations

CA (6); US (17)