Clinical Trial: An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: RDD Pharma Ltd

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients . [ Time Frame: 8 weeks ]

safety will be assessed by the number of participants with adverse events. Tolerability will be assessed by the number of participants that discontinue treatment.


Original Secondary Outcome: Same as current

Information By: RDD Pharma Ltd

Dates:
Date Received: December 11, 2013
Date Started: March 2014
Date Completion:
Last Updated: November 15, 2015
Last Verified: January 2015