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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Macabi outpatient clinic
Beersheba, Negev, Israel
Macabi HMO outpatient clinic
Tel Aviv, Tel Aviv, Israel
Macabi outpatient clinic
Rehovot, Israel
Asaf Harofe Hospital
Zrifin, Israel
To examine the effect of coated Nifedipine suppository on Anal fissure pain as measured by Visual Analog Score
Time frame: 8 weeks after study initiation
To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients .
safety will be assessed by the number of participants with adverse events. Tolerability will be assessed by the number of participants that discontinue treatment.
Time frame: 8 weeks
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