Clinical Trial: An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects

Brief Summary: This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal fissure.

Detailed Summary: This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine. Approximately 20 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) 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). 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. [ Time Frame: 8 weeks ]
  • To examine the effect of coated Nifedipine suppository on Anal fissure healing. [ Time Frame: 8 weeks ]


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 ]

Original Secondary Outcome: Same as current

Information By: RDD Pharma Ltd

Dates:
Date Received: September 8, 2009
Date Started: December 2009
Date Completion:
Last Updated: February 15, 2011
Last Verified: February 2011