CTRI/2021/02/030971已完成3 期
A Prospective, Randomized, Open-Label, Comparative,Multicentric Phase III Clinical Study to Evaluate the Efficacy andSafety of Fixed Dose Combination of Diltiazem Hydrochloride2% w/w and Lidocaine Hydrochloride 2% w/w Gel againstDiltiazem Hydrochloride Gel 2% w/w in the Treatment of AnalFissure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 12
- 主要终点
- Mean reduction in anal pain intensity (on 100 mm VAS)between test group and reference group
研究概览
简要总结
This is Prospective, Randomized, Open-Label, Comparative, Multicentric Phase III Clinical Study will be conducted Approximately 8 to 12 centers across India to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diltiazem Hydrochloride 2% w/w and Lidocaine Hydrochloride 2% w/w Gel against Diltiazem Hydrochloride Gel 2% w/w in the Treatment of Anal Fissure and 326 Patients will be enrolled between age of 18 to 64.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal fissure 2) Patients with anal fissure having moderate to severe anal pain (VAS score ≥ 45 mm on 100 mm VAS scale) at baseline 3) Females of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use an adequate and reliable contraception (defined as intrauterine device, contraceptive pill or progesterone) throughout the study 4) Patients who are willing to comply with the study procedures and requirements 5) Patients who are willing to stop all other concomitant topical preparations applied peri-anally prior to commencing the study product and throughout the study Patients who understand the requirement of the study and are willing to sign and date the informed consent before participating in the study.
排除标准
- •Patients unwilling to have an examination of anal fissure 2) Patients having anal fistulas or anal fissure of various causes such as Crohn disease, anal suppuration, and abscesses 3) Patients who have a history of or active gastrointestinal disorders like inflammatory bowel disease, chronic fecal incontinence or a history of chronic constipation or constipation in 4 weeks prior to screening (defined as 2 or less defecations per week; associated with straining/passage of hard stools), anal abscess, or fixed anal stenosis/fibrosis 4) Patients with a history of neoplastic disease within 5 years 5) Patients with associated acute hemorrhoidal attacks 6) Patients having anal or peri-anal cancer 7) Patients who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region or have a history of radiation therapy to the pelvis 8) Patients with a history of hepatic or renal impairment 9) Patients with a clinically significant history of renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or hematological illness or any clinically significant abnormal laboratory findings (as per Investigator’s assessment from medical records) 10) Patients of hypertension / ischemic heart disease on oral calcium channel blockers (CCBs) 11) Patients with anal fissure associated with other conditions (drug-induced [e.g. nicorandil], trauma, human immunodeficiency virus infection, fistula-in-ano, inflammatory bowel disease, peri-anal sepsis or malignancy) 12) Patients with a history of cardiovascular disease, history of reduced left ventricular function, bradycardia, first degree atrioventricular block or prolonged PR interval (> 0.2 seconds / > 200 milliseconds) on ECG 13) Patients with a history of or active uncontrolled diabetes and/or hypertension 14) Patients who have previously received therapy with Diltiazem hydrochloride gel, other topical CCBs or other topical medicated ointments etc.
- •for past 3 days before screening 15) Patients with a history of human immunodeficiency virus or viral hepatitis positivity 16) Patients with a history of hypersensitivity to amide type local anesthetics or Diltiazem 17) Patients who have been previously treated surgically and patients taking oral CCBs, nitrates, or any other vasodilators 18) Patients taking medications prohibited by the protocol 19) Patients with symptoms suggestive of urinary tract infection 20) Patients who are unsuitable for any other reason to participate in the study in the opinion of the Investigator.
结局指标
主要结局
Mean reduction in anal pain intensity (on 100 mm VAS)between test group and reference group
时间窗: from baseline (prior to application) to Day 10
次要结局
- Mean reduction in anal pain intensity (on 100 mm VAS)within test group and reference group(from baseline (prior to application) to Day 10)
- Reduction in itching (on a 5-point scale) and bleeding (recorded as peri-anal(bleeding score))
- Mean time to complete healing of anal fissure(Day 1 to Day 40)
- Mean reduction(in anal pain intensity (on 100 mm VAS))
- Patient and Investigator global assessment of treatment(at Day 5, Day 10, Day 25, and Day 40)
- Onset of some / partial relief in pain on Day 1 (0.5 hour, 1 hour, 2 hours, 4 hours,(and 8 hours after first application) between test group and reference group on a 5-)
- Proportion of patients with partial / complete healing of anal fissure(At Day 5, Day10, Day 25, and Day 40)
- Number of rescue medication (Diclofenac 50 mg) tablets and the average daily dose(taken by a patient)
研究者
研究点 (12)
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