Trials / Terminated

TerminatedNCT02023047

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

Status: Terminated
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 33 (actual)

Sponsor: RDD Pharma Ltd · Industry
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

Summary

Detailed 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.

Conditions

Anal Fissure

Interventions

Type	Name	Description
DRUG	Nifedipine 12 mg coated suppositories

Timeline

Start date: 2014-03-01
Primary completion: 2015-11-01
Completion: 2015-11-01
First posted: 2013-12-30
Last updated: 2015-11-17

Locations

4 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT02023047. Inclusion in this directory is not an endorsement.