CTRI/2024/12/078489已完成3 期
A Randomized, Double-Blind, Multicenter, Parallel- Group, Two Arm, Placebo-Controlled Study to Assess the Efficacy and Safety of Diltiazem Hydrochloride 2 percentage Gel in the Treatment of Chronic Anal Fissure.
Morningside Healthcare14 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2025年1月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 14
- 主要终点
- Proportion of subjects for which CAF healing is observed during the 8-week treatment period.
研究概览
简要总结
A study is A Multicenter, Randomized, Double-Blind, Two-Arm, Placebo-Controlled, Parallel Design study. This clinical trial intended to Evaluate the Efficacy and Safety of Diltiazem hydrochloride 2% gel of Morningside Healthcare, UK with Placebo gel of Morningside Healthcare, UK in Subjects with Chronic Anal Fissure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •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 fibre 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
- •Subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Institutionalized subjects.
- •Subject presenting with any of the clinical conditions mentioned below: a.
- •acute anal fissure (i.e. duration of symptoms less than 4 weeks prior to screening, and/or no induration of fissure edges).
- •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 faecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis.
- •Subjects unwilling to have examination of anal fissure.
- •Subject who have 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, etc.), anal or peri-anal sepsis.
- •Subject with history or presence of malignant disease.
- •Subject with clinically significant cardiovascular disorder (including those diagnosed by the screening ECG), namely New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation, atrioventricular block, clinically significant bradycardia or prolonged P-R interval
- •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 randomization to end of treatment.
- •Subject with respiratory insufficiency and need for long-term oxygen therapy or home ventilation.
- •Subject with known neuromuscular disease.
- •Subject with any changes in the previous 8 weeks to oral, sublingual or intra-muscular therapy with vasodilators (beta-blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants.
- •Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
- •Previous treatment with Diltiazem Hydrochloride cutaneous formulations or any other topical calcium channel blockers in the 8 weeks before randomization.
- •Subject who used an analgesic, anaesthetic, cicatrizant, other topical vasodilators, corticosteroid, vitamin A or E, or any other active substances that might be active in anal mucosa regeneration, less than 3 days before screening.
- •History of hypersensitivity or intolerance to any of the investigational medicinal products, or to their active substances or excipients, or to similar drugs.
- •Subject with clotting disorders.
- •Subject who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
- •Any other clinically significant abnormal findings or condition (other than anal fissure), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
结局指标
主要结局
Proportion of subjects for which CAF healing is observed during the 8-week treatment period.
时间窗: Week 4 (±2 days), Week 6 (±4 days), Week 8 (±4 days).
次要结局
- 1. Proportion of subjects for which CAF healing is observed until the 6th week of treatment.(2. Proportion of subjects for which CAF healing is observed until the 4th week of treatment.)
研究者
Dr Dharmesh Domadia
Cliantha Corporate
研究点 (14)
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