Status and phase
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About
This is an open label study. The study will consist of 2 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2). Approximately 30 subjects will participate into this 8-week study. The primary objective is to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and healing.
Full description
This is an open label study. The study will consist of 2 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2). Approximately 30 subjects will participate into this 8-week study. A screening visit will be used to determine subject suitability for inclusion in the trial. Within one week of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will receive Coated Nifedipine 12 mg Suppository X2 a day (BID) (24 mg/day total) OR Coated Nifedipine 12 mg Suppository X1 a day (OD) (12 mg/day total) for a period of 8 weeks. During this period, 4 study visits (at 0, 2, 5, and 8 weeks) will take place. Study medication will be administered BID (in the morning and in the evening) or OD (only in the morning). In addition to receiving study medication, subjects will be maintained on a standard treatment for Anal Fissure: sitz baths, high fiber diet.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Known allergy to Nifedipine, polyethylene-glycol, propylene Glycol or silicone.
Fissure resulting from inflammatory bowel disease, venereal disease, perianal psoriasis, immunodeficiency syndrome.
Anal abscess
Fixed anal stenosis
Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, moderate to severe congestive heart failure, or cardiac valve abnormalities;
Type 1 diabetes mellitus;
Insulin treated type 2 diabetes mellitus;
History of Renal insufficiency.
History of Liver insufficiency.
Malignant disease within 5 years of screening;
Has uncontrolled hypertension (sitting blood pressure <160/95 mmHg at screening)
History of chronic gastrointestinal disease.
History of rectal surgery.
History of gastrointestinal surgery.
History of HIV, hepatitis B, hepatitis C.
In need of chronic use of medication, with the exception of birth control medications.
Currently uses medication for acute illness (other than medications for use of treatment/pain relief of anal fissure).
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.
Is using drug that may affect rectal tone:
Calcium Channel Blocker such as:
Nitrate donors such as:
Has upon physical examination a rectal deformation or signs of rectal disease such as bleeding hemorrhoids, fistula. infection or space occupying lesion.
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 by RDD Pharma Ltd.
Primary purpose
Allocation
Interventional model
Masking
33 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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