Single-Site, Double-Blind, Flexible-Dose, Placebo-Controlled Study of the Efficacy, Tolerability, & Safety of Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in: Changes in Mean composite pain scores (on IVRS)
研究概览
简要总结
Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population, affecting somewhere between 9-22% based on community based studies. IBS has a chronic relapsing course and overlaps with other functional gastrointestinal disorders. It accounts for high direct medical expenses and indirect costs including a significant degree of absenteeism. Most studies have suggested that there is a slight predominance among women, especially those that have suffered some form of physical or sexual trauma. It has been estimated that up to 25-40% of patients seen by gastroenterologists' are affected by IBS, and that 70-90% of these patients may have a psychiatric comorbidity, most commonly major depression and panic disorder, but also including schizophrenia, double depression, dysthymia and alcohol abuse.
Abdominal pain and disturbance of bowel habits characterize the symptoms of IBS in the absence of demonstrable structural pathology. The diagnosis of IBS relies upon clinical criteria alone, as there is no "gold standard" in laboratory findings. The diagnosis is dependent upon identifying characteristic symptoms, and then differentiating IBS from other structural bowel disorders. Previously, the diagnosis of IBS was based upon a consortium recommendation that examined and defined diagnostic criteria for over 100 functional gastrointestinal disorders. These criteria became the most definitive in the area of functional disorders and are referred to as the Rome Criteria. During the time since this consensus, these criteria have been modified, and in 1999 became the foundation for the second set of diagnostic criteria by consensus, now referred to as the Rome II criteria. The revised Rome II criteria include only the first part of the original criteria, but now require the presence of two out of three symptoms relating abdominal pain to bowel symptoms.
We designed our study and a Randomized, double-blind, parallel-group, flexible-dose, placebo-controlled 12-week study.
详细描述
Primary and Secondary Efficacy Measures Primary
Change from baseline in:
• Mean composite pain scores (on IVRS) Secondary
Change from baseline in:
- Associated symptoms of IBS (diarrhea, constipation, incomplete emptying, etc.) scores
- IBS Quality of Life scores
- Clinical Global Impression scores of 1 or 2
- Beck Depression Inventory II
- Beck Anxiety Inventory
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Those in the active treatment group will receive doses of Paxil CR in increments of 12.5 mg daily for the first week and increased at 12.5 mg increments at visit weeks to a maximum of 50 mg daily, as determined by the investigator. The investigator will adjust dosage based on clinical response. Following the completion of the double-blind phase, patients on placebo and non-responders to the study drug will be tapered off the study drug back to 0 over 2 weeks, and they will be referred to their Primary Care Physician, Internist or Gastroenterologist to be prescribed treatment for Irritable Bowel Syndrome.
干预措施: Paroxetine CR (Drug)
2
Same shape placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in: Changes in Mean composite pain scores (on IVRS)
时间窗: 12 weeks
次要结局
- Change from baseline in Associated symptoms of IBS (diarrhea, constipation, incomplete emptying, etc.) scores IBS Quality of Life scores Clinical Global Impression scores of 1 or 2 Beck Depression Inventory II Beck Anxiety Inventory(12 weeks)
- Recording of spontaneous adverse events throughout the screening, run-in, and treatment phases of the study Conducting the DOTES at defined points during the study(12 weeks)