NCT01456052已完成2 期
Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis
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
- 59
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing a Treatment Emergent Adverse Event
研究概览
简要总结
This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ulcerative colitis of at least 6 months duration
- •Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
- •Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
- •Age ≥18 and <70 years of age
- •Able and willing to provide written informed consent
排除标准
- •Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- •Clinical signs of fulminant colitis or toxic megacolon
- •History of dysplasia associated lesion or mass (DALM)
- •Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
- •History of primary sclerosing cholangitis
- •Any physical or laboratory abnormality deemed by the investigator as clinically significant
- •Major surgery within 60 days of Screening
- •Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening
研究组 & 干预措施
Low Dose Telotristat Etiprate
Experimental
500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
干预措施: Telotristat Etiprate (Drug)
High Dose Telotristat Etiprate
Experimental
500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
干预措施: Telotristat Etiprate (Drug)
Placebo
Placebo Comparator
Matching placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing a Treatment Emergent Adverse Event
时间窗: 8 weeks
次要结局
- Number of Participants Achieving Clinical Response(Baseline to 8 weeks)
- Number of Participants Achieving Clinical Remission(Baseline to 8 weeks)
- Change From Baseline in Total Modified Mayo Score(Baseline to 8 weeks)
研究者
研究点 (1)
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