CTRI/2022/07/044499尚未招募未知
An Investigator initiated Single-Arm Pilot Study to Assess the Efficacy and Safety of Diltigesic 2% w/w Organogel (Diltiazem Hydrochloride Gel) in the Treatment of Chronic Anal Fissure.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or non-pregnant, non-lactating female aged 18 years old or above.
- •2. Diagnosis of idiopathic chronic anal fissure unresponsive to previous therapy (e.g. stool softeners, a high fiber diet, and a warm sitz bath). Chronic anal fissure defined as anal fissure persisting longer than 6 weeks prior to screening and showing the presence of at least one of
- •the following:
- •- sentinel skin tag
- •- hypertrophied anal papillae
- •- exposed internal anal sphincter
- •- fibrotic fissure margins
- •- fibrotic anal sphincter
- •3. If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- •4. Able to comply with the study requirements and procedures as per protocol.
- •5. Willing to provide written informed consent.
排除标准
- •1. Institutionalized subject.
- •2. Subject 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.
- •3. Subject with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis.
- •4. Subject who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region.
- •5. Subject treated with botulinum toxin less than 6 months prior to enrolment.
- •6. Subject 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 (e.g. HIV, Syphilis, etc.), anal or peri-anal sepsis.
- •7. Subject with history or presence of malignant disease.
- •8. Subject with clinically significant cardiovascular disorder, namely
- •New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia.
- •9. Subject with orthostatic (postural) hypotension (i.e., a drop in systolic blood pressure of 30 mmHg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing).
- •10. Unwilling to discontinue use of sitz baths for up to 4 hours after application of investigational product and unwillingness to limit sitz baths to one per day from treatment assignment to end of treatment.
- •11. Subject with respiratory insufficiency and need for long-term oxygen therapy or home ventilation.
- •12. Subject with clinically significant renal failure.
- •13. Subject with known neuromuscular disease.
- •14. Subject with any changes in the previous 12 weeks to oral, sublingual or intra-muscular therapy with vasodilators (beta-blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants.
- •15. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
- •f. Fissure at locations other than the midline.
- •g. Fissure unassociated to sphincter spasm.
- •3. Subject with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis.
- •4. Subject who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region.
- •5. Subject treated with botulinum toxin less than 6 months prior to enrolment.
- •6. Subject 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 (e.g. HIV, Syphilis, etc.), anal or peri-anal sepsis.
- •7. Subject with history or presence of malignant disease.
- •8. Subject with clinically significant cardiovascular disorder, namely New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia.
- •9. Subject with orthostatic (postural) hypotension (i.e., a drop in systolic blood pressure of 30 mmHg or more and/or a drop in diastolic blood pressure of 20
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