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
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) Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal
- •2) Patients with anal fissure having moderate to severe anal pain (VAS score ââ?°Â¥ 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
- •1) 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
- •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
- •Investigatorââ?¬•s assessment from medical records)
- •10) Patients of hypertension / ischemic heart disease on oral calcium channel blockers
- •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
研究者
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