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

NCT02023047 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-11-17

No results posted yet for this study

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.

Conditions

  • Anal Fissure

Interventions

DRUG

Nifedipine 12 mg coated suppositories

Sponsors & Collaborators

  • RDD Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Nir Barak, MD · RDD Pharma Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023047 on ClinicalTrials.gov