EUCTR2010-023938-23-IT进行中(未招募)不适用
Effect of Mesalazine plus nifedipine suppositoires (Antrorect) in functional ano-rectal pain disorders: a pilot randomized double-blind placebo-controlled study. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- BRACCO
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients who have given their free and informed consent. • Male or female patients aged between 18 and 70 years. • A positive diagnosis of functional ano-rectal pain, according to Rome III criteria1. • At least ano-rectal pain once a week in the last 3 months with symptom onset at least 6 months prior to diagnosis (to be confirmed also after the run-in period) • Patients capable of conforming to the study protocol (patient’s diary to be filled in daily) and to co-operate with the treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with organic causes of ano-rectal pain such as hemorrhoidal thrombophlebitis, ischemia, IBD, cryptitis, intramuscular abscess, anal fissures, hemorrhoids (III and IV degree), prostatitis, and coccygodynia. First and second degree haemorrhoids do not represent an exclusion criteria. • Patients with previous ano-rectal surgery at least 5 years apart. • Hypersensitivity or allergy to nifedipine, mesalazine, other salicylates (including aspirin), or to any component of the rectal suppositories, including the suppository vehicle. • Pregnancy and breastfeeding as well as females of childbearing potential, in the absence of effective contraceptive methods. • Presence of severe psychiatric disorders (e.g. bipolar disorder, eating disorders, alcohol or drug addiction, etc). • Treatment with any investigational drug within the previous 30 days.
研究者
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