EUCTR2008-005172-26-GB进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Diltiazem Hydrochloride Cream in Subjects with Anal Fissure - Diltiazem hydrochloride cream for anal fissure.
S.L.A. Pharma (UK) Ltd0 个研究点目标入组 465 人开始时间: 2010年7月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 465
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Must give written informed consent.
- •- Male or female subjects = 18 years of age.
- •- Subjects with at least a 4 week history of painful AF prior to screening, where
- •AF-related pain associated with, or following, defaecation is experienced at least
- •twice a week for the 4 weeks prior to screening with an average of = 3 on an
- •11-point NRS.
- •- Subjects with an average of =4, on an 11-point NRS, during the screening phase, for
- •worst anal pain associated with, or following, defaecation for the most recent three
- •days on which the subject has defaecated.
- •- Subjects with evidence of a circumscribed fissure, with induration at the edges.
- •- Willing to stop all other concomitant topical preparations applied perianally prior to
- •commencing study treatment and throughout the study.
- •- Willingness and ability to use the IVRS diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects unwilling to have examination of AF.
- •- Subjects with acute” AF (i.e. duration of symptoms less than 4 weeks prior to
- •screening, and/or no induration of fissure edges).
- •- More than one AF.
- •- Subjects who have had lateral sphincterotomy or anal stretch or other previous
- •surgery involving the anal canal or perianal region.
- •- Subjects who have had subfissure injection of botulinum toxin in the 3 months prior
- •to screening, or have used GTN ointment for >1 week in the 4 weeks prior to the
- •screening visit.
- •- Subjects with AF associated with other conditions (drug-induced [e.g. nicorandil],
- •trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or
- •malignancy).
- •- Subjects with cardiovascular disease (including those diagnosed by screening ECG):
- •history of reduced left ventricular function, bradycardia, 1st degree AV block or
- •prolonged PR interval (>0.2 seconds/ >200 milliseconds).
- •- Subjects with known hypersensitivity to diltiazem.
- •- Subjects who have previously received therapy with diltiazem hydrochloride cream or
- •other topical calcium channel blockers.
- •- Subjects taking prohibited medications.
- •- Subjects who have taken experimental agents must have been discontinued at least
- •8 weeks prior to screening, or for a period equivalent to 5 half-lives (t1/2) of the
- •agent (whichever is longer);
- •- Subjects who have or who have undergone the following gastrointestinal disorders
- •and procedures:-
- •- Inflammatory bowel disease.
- •- Chronic faecal incontinence.
- •- History of chronic constipation or constipation in the 4 weeks prior to the
- •screening phase (defined as 2 or less defaecations per week; associated with
- •straining/passage of hard stools).
- •- Anal abscess.
- •- A history of radiation therapy to the pelvis.
- •- Fixed anal stenosis/fibrosis.
- •- Subjects with a history of neoplastic disease within 5 years (except for basal cell
- •carcinoma or non-metastatic squamous cell carcinoma of the skin).
- •- Subjects with a clinically significant history of renal, hepatic, neurological,
- •dermatological, immunological, major psychiatric (including drug or alcohol abusers),
- •or haematological illness.
- •- Subjects with any laboratory test/ECG results considered clinically significant at
- •- Subjects with planned elective or other treatment requiring hospitalisation, during
- •the study, booked before entry into the study
- •- Subjects who will be unavailable for the duration of the trial, likely to be
- •noncompliant with the protocol, or who are felt to be unsuitable by the Investigator
- •for any other reason.
- •- Women of childbearing potential unless surgically sterile or using adequate
- •contraception (either intrauterine device [IUD], oral or depot contraceptive, or barrier
- •plus spermicide), and willing
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