EUCTR2015-003627-54-CZ进行中（未招募）1 期
Randomized, multicenter, placebo-controlled, double blind study to assess the efficacy and tolerability of 2% diltiazem hydrochloride in the treatment of chronic anal fissure and a 24 week follow-up period - EFAC II
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •1. Patients aged 18 years old or above;
- •2. Diagnosis of idiopathic chronic anal fissure unresponsive to previous therapy;
- •3. Patient able to comply with the study protocol as per investigator criteria;
- •4. Signed and dated informed consent by the patient or his/her representative/witness (as per applicable law);
- •5. Absence of any exclusion criterion
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Patient presenting with any of the clinical conditions mentioned below:
- •a. Anal fissure lacking features for chronicity;
- •b. Cured anal fissure;
- •c. Infected chronic anal fissure;
- •d. Multiple fissures;
- •e. Fissure with irregular margins;
- •f. Fissure at locations other than the midline;
- •g. Fissure unassociated to sphincter spasm;
- •2. Patients with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis;
- •3. Patients with prior anal surgery;
- •4. Patients treated with botulinum toxin less than 6 months prior to enrolment;
- •5. Patients with chronic anal fissure secondary to other disorders such as chronic inflammatory bowel disease, intestinal tuberculosis, anal or peri-anal cancer, anal fistula, sexually transmitted diseases, anal or peri-anal sepsis;
- •6. Patients with malignant diseases and a life expectancy of less than 1 year or patients undergoing chemo- or radiotherapy less than 6 months prior to enrolment;
- •7. Patients with clinically significant cardiovascular disorder, namely New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation or atrial flutter caused by Wolff-Parkinson-White or Lown-Ganong-Levine syndromes, second and third degree atrioventricular block or sinoatrial node disease (except in the presence of a functioning artificial ventricular pacemaker), myocardial infarction with an ejection fraction below 0.40, ventricular tachycardia, severe bradycardia (lower than or equal to 40 beats per minute) or severe aortic stenosis.;
- •8. Patients with orthostatic (postural) hypotension or severe hypotension (systolic blood pressure below 90 mmHg);
- •9. Patients with respiratory insufficiency and need for long term oxygen therapy or home ventilation;
- •10. Patients with clinically significant renal failure;
- •11. Patients with known human immunodeficiency virus (HIV) infection;
- •12. Patients with known neuromuscular disease;
- •13. Pregnant or lactating patients;
- •14. Women of childbearing potential who are sexually active and who do not use an effective contraceptive method.
- •15. Patients with any changes in the previous 12 weeks to oral, sublingual, intravenous or intra-muscular therapy with vasodilators (beta blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants (for example infusion of dantrolene);
- •16. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
- •17. Previous treatment with diltiazem hydrochloride cutaneous formulations or any other topical calcium channel blockers in the 8 weeks before randomization.
- •18. Patients who used an analgesic, anesthetic, cicatrizant, other topical vasodilators, corticosteroid, vitamins A or E, or any other active substances that might be active in anal mucosa regeneration, less than 3 days before.
- •19. History of hypersensitivity or intolerance to any of the investigational medicinal products, or to their active substances or excipients, or to similar drugs;
- •20. Patients with clotting disorders, unless the patients are taking anticoagulants drugs and the investigator considers that the International Normalized Ratio (INR) is adequate and stable;
- •21. Any known abnormal clinical or laboratory change that, as per the investigator, might interfere with the safety or efficacy assessment or any study procedure;
- •22. Patients who have participated in another clinical trial less than one month prior to enrolment or who are still involved in
研究者
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