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drugset / Trial / NCT02023047

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

NCT02023047 ↗

Phase 1/2 Terminated 33 enrolled RDD Pharma Ltd
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-03
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Nifedipine Other / unclassified 12 mg Rectal

Indications

No indication recorded.