EUCTR2014-003351-65-BG进行中（未招募）1 期
The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients with Anal Fissure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- 性别
- All
入选标准
- •Subjects meeting the following criteria will be eligible to participate in the trial:
- •1.Single anal fissure;
- •2.Signed written informed consent;
- •3.Male or female subjects 18 to 65 years of age inclusive;
- •4.Has chronic anal fissure defined as history of rectal pain at least three days a week for at least 6 weeks - or more AND at least one of the following:
- •a)Sentinel skin tag
- •b)Hypertrophied anal papilla
- •c)Exposure of the underlying internal anal sphincter
- •d)Anal cicatrisation
- •5.Visual analogue scale of average 24 hours rectal pain (VAS) of > 40 mm in screening visit;
- •6.Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator;
- •7.If female, is non-lactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to entry to the study or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice or be willing to continue to practice acceptable birth control from screening and until 1 week after the study medication has been discontinued.
- •Acceptable birth control includes :
- •a)combined (estrogen and progestogen containing) hormonal contraception
- •b)associated with inhibition of ovulation; oral OR intravaginal OR transdermal.
- •c)progestogen-only hormonal contraception associated with inhibition of ovulation: oral OR injectable OR implantable.
- •d)progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •e)intrauterine device (IUD)
- •f)intrauterine hormone-releasing system ( IUS)
- •g)bilateral tubal occlusion
- •h)vasectomised partner
- •i)sexual abstinence
- •j)male or female condom with or without spermicide
- •k)cap, diaphragm or sponge with spermicide
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Subjects are excluded from participation in the study if any of the following criteria apply:
- •1.Known allergy to Nifedipine
- •2.Unwilling to stop all other concomitant topical preparations applied in and around the anus from screening through the end of the study
- •3.Subfissure injection of botulinum toxin in the 3 months prior to screening.
- •4.Fissure resulting from inflammatory bowel disease, venereal disease, perianal psoriasis, immunodeficiency syndrome
- •5.Atypical fissure (occurs off the midline) in which secondary causes were not excluded.
- •6.Deemed by the investigator as anal fissure for which surgery is indicated
- •7.Anal abscess;
- •8.Grade 4 hemorrhoids
- •9.Fixed anal stenosis
- •10.Active or past history of cardiovascular or cerebrovascular disease including but not limited to angina pectoris, myocardial infarction, transient ischemic attacks/stroke, arrhythmia or ecg changes that requires medical treatment or deemed by the investigator as clinically significant, moderate to severe congestive heart failure, or cardiac valve abnormalities;
- •11.Type 1 diabetes mellitus
- •12.Insulin treated type 2 diabetes mellitus
- •13.Renal failure defined as a serum creatinine > 1.5 mg/dL (133 µmol/L) at screening
- •14.Liver disease defined as Aspartate aminotransferase (AST) or alanine aminotransferase(ALT) >2 X upper limit of normal at screening
- •15.Malignant disease within 3 years of screening
- •16.Has uncontrolled hypertension (sitting blood pressure >160/95 mmHg at screening)
- •17.Has hypotension (blood pressure lower than 90/60 mm Hg at screening)
- •18.History of chronic gastrointestinal disease such as Crohn’s disease or ulcerative colitis
- •19.History of major rectal surgery
- •20.History of HIV, Hepatitis B, Hepatitis C
- •21.Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator at screening;
- •22.Has used, in the last two weeks, drugs that may affect blood coagulation, such as Aspirin at a dose higher than 500 mg/day, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine Rivaroxaban, Apixaban, Edoxaban
- •23.Is treated with drugs that may affect the anal sphincter:
- •a.Calcium channel blockers such as Nifedipine, Diltiazem or Verapamil
- •b.Nitroglycerin or nitrates
- •24.Has, upon physical examination, a rectal deformation or signs of rectal disease such as fistula, infection or space occupying lesion;
- •25.Participated in a clinical study in the last 30 days prior to screening.
- •26.Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or is employed or related to the Sponsor, CRO or investigator;
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