A Phase 2 PoC in IBS Patients With the CRF1 Receptor Anatgonist, GSK876008
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
GW876008
GW876008
干预措施: GW876008 (Drug)
Placebo
Placebo
干预措施: GW876008 (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
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).
时间窗: Up to Day 105 (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.
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).
时间窗: Up to Day 105 (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.
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
时间窗: Up to Day 105
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.
Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen
时间窗: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
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.
Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale
时间窗: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
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.
次要结局
- 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)
- IBS Composite Symptom Score(Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2))
- 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))
- Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment(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)(Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2))