Topical Voltaren in Otitis Externa

April 18, 2016 updated by: victor kizhner, Sieff Medical Center

Topical Voltaren as an Alternative Treatment for Otitis Externa

Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, 13100
        • Sieff Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults having otitis externa as single diagnosis mild to moderate

Exclusion Criteria:

  • Diabetes
  • Children
  • Pregnant women
  • Immune compromise
  • Starting other treatment
  • Moderate to severe otitis externa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
voltaren ophta
Drug: diclofenac sodium
topical solution used in ear 5 drops 8 3/day
Other Names:
  • voltaren ophta
Active Comparator: 2
dexotic
Drug: dexotc
aural drops
Other Names:
  • dexotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reducing oral analagestic use
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
adding an alternative treatment for otitis externa
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sieff Medical Center

Investigators

  • Principal Investigator: victor kizhner, m.d., Sieff Medical Center, Safed, ISRAEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP 7-264S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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