CTRI/2022/07/044499尚未招募不适用
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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Safety:
研究概览
简要总结
| This is an Investigator initiated single arm study. Subjects will have to visit the clinic for the following visits during the study: |
Visit 1 Screening visit (within 2 weeks prior to baseline visit)
Visit 2 Baseline visit (Day 0)
Visit 3 Interim visit at 2 weeks (±02 days)
Visit 4 End of Study at 4 weeks (± 04 days)/ Early termination visit
Subjects will participate in the study related screening activities, after obtaining the informed consent. Screening will be performed within 2 weeks prior to baseline visit during which eligibility will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female aged 18 years old or above.
- •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 or.
- •fibrotic anal sphincter
- •If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- •Able to comply with the study requirements and procedures as per protocol.
- •Willing to provide written informed consent.
排除标准
- •Institutionalized subject.
- •Subject presenting with any of the clinical conditions mentioned below: a.
- •Anal fissure lacking features for chronicity.
- •Cured anal fissure.
- •Infected chronic anal fissure.
- •Multiple fissures.
- •Fissure with irregular margins.
- •Fissure at locations other than the midline.
- •Fissure unassociated to sphincter spasm.
- •Subject with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis.
- •Subject who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region.
- •Subject treated with botulinum toxin less than 6 months prior to enrolment.
- •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.
- •Subject with history or presence of malignant disease.
- •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.
- •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).
- •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.
- •Subject with respiratory insufficiency and need for long-term oxygen therapy or home ventilation.
- •Subject with clinically significant renal failure.
- •Subject with known neuromuscular disease.
- •Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
结局指标
主要结局
Safety:
时间窗: 04 Weeks
Proportion of subjects for which healing rate is observed during the 4 weeks treatment period.
时间窗: 04 Weeks
次要结局
- Efficacy(Mean change in pain score based on VAS from baseline to Week 4.)
研究者
研究点 (2)
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