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临床试验/NCT04217733
NCT04217733招募中3 期

A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome

详细描述

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •• Age ≥ 18 years,
  • •Man and Women, Negative pregnancy test and effective contraception,
  • •IBS defined by the Rome criteria IV
  • •During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥
  • •IBS Treatment stable for 1 month

排除标准

  • •• Breastfeeding
  • •Diabetic patients
  • •Significant liver function abnormalities (transaminases> 3N, cholestasis) and moderate renal disease (MDRD <60 ml / min)
  • •Addiction to alcohol and / or drugs,
  • •Antiepileptic drugs taken (epilepsy or chronic pain)
  • •Chronic pain of greater intensity than that related to IBS,
  • •Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.
  • •History or current severe depression (hospitalization, long-term antidepressant treatment)
  • •Psychotic disorders,

研究组 & 干预措施

Mebeverine

Active Comparator

Mebeverine 3 times daily for 3 months

干预措施: Mebeverine (Drug)

Ethosuximide

Experimental

Ethosuxemide 3 times daily for 3 months

干预措施: ethosuximide (Drug)

Pentoxyifylline

Experimental

pentoxyifylline 2 times daily for 3 months

干预措施: pentoxyifylline (Drug)

结局指标

主要结局

Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS

时间窗: 6 months

the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Tanta University

研究点 (1)

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Ethosuximide and Pentoxifylline in the Treatment of... | 临床试验