Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 67
- 主要终点
- IBS pain severity
研究概览
简要总结
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
详细描述
This observational study will evaluate the effect of Lotronex® as used in the current clinical practice setting on symptom relief, specifically, improvement in bowel habits and IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be consented for study participation. Patients will complete study questionnaires related to bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome. Investigators will also be asked to complete questionnaires related to the patient's disease characteristics, patient progress on study medication and treatment outcome.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be a female between 18 and 65 years of age (inclusive) at Visit
- •Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
- •Be diagnosed with severe, diarrhea-predominant IBS.
- •Have experienced chronic IBS symptoms lasting 6 months or longer.
- •Have not responded adequately to other IBS therapy.
- •Be able to read, understand and sign the informed consent and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements.
排除标准
- •Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
- •In the past 14 days, has had evidence of chronic or severe constipation, or has a history of chronic or severe constipation, or a history of sequelae from constipation.
- •Has recurrent bowel obstruction of the small intestine or colon.
- •Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
- •Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
- •Has a history of thrombophlebitis or hypercoagulable state.
- •Has a history of atherosclerosis.
- •Has any medical or surgical condition that in the judgment of the investigator makes the patient an inappropriate candidate for Lotronex® therapy (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition; recent or ongoing malignancy; evidence of hepatic dysfunction; or renal impairment.)
- •Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
- •Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
- •Chronic (≥ 6 months) use of narcotics or opioids.
- •The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
- •The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
- •Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.
结局指标
主要结局
IBS pain severity
时间窗: At Weeks 4 and 12
Pain intensity as measured by the 11-point numeric rating scale (NRS) will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined.
Change in stool consistency
时间窗: At Week 4 and Week 12
Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.
次要结局
- Change from baseline stool frequency.(Week 4 and Week 12)
- Change from baseline in fecal urgency.(Week 4 and Week 12)
- Change from baseline in lost productivity.(12 Weeks)
- Change from baseline in quality of life scores (IBSQOL).(Week 12)