CTRI/2024/09/073830已完成Unknown
A Prospective, Open Label, Single-Arm, Non-Comparative, Study to Evaluate The Effectiveness & Safety Of Formulation Of Nifedipine and Lidocaine In Treatment Of Anal Fissure
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- 1. The mean change in pain scores as measured by VAS from baseline (Day 1) to Week 6, post-treatment with the fixed-dose formulation of nifedipine and lidocaine in patients with anal fissures.
研究概览
简要总结
This is a prospective, single-center, single-arm, open-label study designed to evaluate the effectiveness and safety of fixed-dose formulation of nifedipine 0.3% w/w and lidocaine 1.5% w/w to be applied topically in the management anal fissures in patients in the age group of 18 years and above. This study will enroll approximately 50 adult patients with anal fissures. The patients will be followed up for 6 weeks after enrollment into the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged 18 years and above, with a diagnosis of Acute or Uncomplicated Chronic anal fissure.
- •Patients with anal fissures who had moderate to severe anal pain (VAS score ≥45 mm [4.5 cm] on 100 mm [10 cm] VAS scale) at baseline.
- •Women of childbearing potential who had a negative pregnancy test, were non-lactating and were willing to use adequate and reliable contraception (defined as intrauterine device, contraceptive pill, or progesterone) throughout the study
- •Patients willing to comply with study procedures and requirements.
- •Patients willing to stop all other concomitant topical preparations applied peri-anally prior to commencing the study product and throughout the study.
- •Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study.
排除标准
- •Patients unwilling to have an examination of anal fissures.
- •Patients with complicated Chronic Anal fissures (With Infections), Anal fistulas, or anal fissures of various causes such as Crohns disease, anal suppuration, and abscesses.
- •Patients with a history of or active gastrointestinal (GI) disorders like inflammatory bowel disease, chronic fecal incontinence, or a history of chronic constipation or constipation in 4 weeks before screening (defined as 2 or fewer defecations per week, associated with straining/passage of hard stools), anal abscess, or fixed anal stenosis-fibrosis.
- •History of neoplastic disease within 5 years.
- •Patients having acute hemorrhoidal attacks.
- •Patients with anal or peri-anal cancer.
- •Patients with a history of lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region or history of radiation therapy to the pelvis.
- •Patients with a history of hepatic or renal impairment.
- •Patients with clinically significant (CS) history of renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or hematological illness or any CS abnormal laboratory findings (as per Investigator’s assessment from medical records).
- •Patients with a history of hypertension/ischemic heart disease and taking oral calcium channel blockers (CCBs).
- •Patients with anal fissures associated with other conditions (drug-induced [e.g., nicorandil], trauma, human immunodeficiency virus infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis, or malignancy).
- •Patients with a history of cardiovascular disease, reduced left ventricular function, bradycardia, first-degree atrioventricular block, or prolonged PR interval (Greater than 0.2 seconds/ Greater than 200 milliseconds) on ECG.
- •Patients with a history of active uncontrolled diabetes (HbA1c Greater than 8%) and/or hypertension (Greater than 140/100 mmHg).
- •Patients with a history of previous therapy with Nifedipine or any other topical CCBs, or other topical medicated ointments for the past 3 days before screening.
- •Patients with a history of positivity for human immunodeficiency virus or viral hepatitis.
- •Patients with a history of hypersensitivity to amide-type local anesthetics or Nifedipine.
- •Patients with a history of previous surgical treatment and use of oral CCBs, nitrates, or any other vasodilators
- •Patients using medications prohibited by the study protocol.
- •Patients with symptoms that are suggestive of urinary tract infection.
- •Pregnant and nursing women.
- •Women with childbearing potential not practicing a reliable method of birth control.
- •Patients with a known history of hypersensitivity to lidocaine and nifedipine.
- •Patients with suspected inability or unwillingness to comply with study procedures.
- •Any unsuitable reasons to participate in the study in the opinion of the Investigator.
结局指标
主要结局
1. The mean change in pain scores as measured by VAS from baseline (Day 1) to Week 6, post-treatment with the fixed-dose formulation of nifedipine and lidocaine in patients with anal fissures.
时间窗: Week 6
次要结局
- 1. Number and percentage of patients achieving healing of the fissure based on the degree of reepithelization of the fissure (scored as, 0: deep fissure still present, 1- superficial fissure, 2- partial reepithelization and 3- complete healing and reepithelization), post-6-weeks treatment with the fixed-dose formulation of nifedipine and lidocaine.(2. Frequency and percentage of patients with anal fissures requiring rescue medication(s), at Week 3 and 6, post-initiation of treatment with the fixed-dose formulation of nifedipine and lidocaine.)
研究者
Dr Rajasekhar Mysore
Chirag Global Hospital
研究点 (3)
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