NCT01989234已完成2 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 65
- 主要终点
- The proportion of subjects with improved bowel movement frequency
研究概览
简要总结
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period.
The objectives of this study are:
- To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation.
- To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet modified Rome II criteria for Chronic Constipation.
- •Patients who are male or female, 18 to 65 years of age inclusive.
- •At Visit 3, patients must have < 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period.
排除标准
- •Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).
- •Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery.
- •Patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of < 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases.
- •Patients with a history of inflammatory bowel disease.
- •Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening.
- •Patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study.
- •Patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine.
研究组 & 干预措施
Placebo Comparator
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
YKP10811 High Dose
Experimental
YKP10811 High Dose
干预措施: YKP10811 (Drug)
YKP10811 Mid Dose
Experimental
YKP10811 Mid Dose
干预措施: YKP10811 (Drug)
YKP10811 Low Dose
Experimental
YKP10811 Low Dose
干预措施: YKP10811 (Drug)
结局指标
主要结局
The proportion of subjects with improved bowel movement frequency
时间窗: 12 weeks
次要结局
- Abdominal pain(12 weeks)
- Onset time to CSBM(12 weeks)
- Daily average ratings of stool consistency(12 weeks)
- Instances of rescue medicine usage(12 weeks)
- Abdominal discomfort(12 weeks)
- Constipation severity(12 weeks)
- Stool frequency(12 weeks)
- Severity of straining(12 weeks)
- Bloating(12 weeks)
- Onset time to SBM(12 weeks)
研究者
研究点 (65)
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