NCT01056783已完成2 期
A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Effect of OC000459 on eosinophil load of the esophageal tissue
研究概览
简要总结
This will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.
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
- •Previously diagnosed and symptomatic isolated eosinophilic esophagitis.
- •Relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load >= 20 eos/hpf in 8 biopsies at the baseline visit.
- •Able to swallow placebo medication successfully under supervision in the clinic
- •Free of all medications for EoE (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. A proton-pump inhibitor is allowed if required for treatment of secondary acid reflux.
排除标准
- •Other causes of esophagitis (GERD, peptic ulceration, infection etc.)
- •Other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, GERD)
- •The patient's EoE is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season.
- •History of abnormal gastric or duodenal eosinophilia (e.g. HES, Churg Strauss vasculitis, EG or a parasitic infection)
- •Receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.
研究组 & 干预措施
OC000459
Experimental
OC000459 100mg twice daily
干预措施: OC000459 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of OC000459 on eosinophil load of the esophageal tissue
时间窗: 8 weeks
次要结局
- Effect of OC000459 on EoE related blood and tissue biomarkers(8 weeks)
- Effect of OC000459 on clinical manifestations of EoE(8 weeks)
- Effect of OC000459 on endoscopic alterations(8 weeks)
- Safety and tolerability of OC000459 in patients with active EoE(8 weeks)
研究者
研究点 (1)
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