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Topical Voltaren in Otitis Externa

Sponsor
Sieff Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00523120
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
39
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Topical Voltaren as an Alternative Treatment for Otitis Externa
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. reducing oral analagestic use [1 week]

    Secondary Outcome Measures

    1. adding an alternative treatment for otitis externa [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sieff Medical Center Safed Israel 13100

    Sponsors and Collaborators

    • Sieff Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    victor kizhner, Victor Kizhner MD, Sieff Medical Center
    ClinicalTrials.gov Identifier:
    NCT00523120
    Other Study ID Numbers:
    • HP 7-264S
    First Posted:
    Aug 30, 2007
    Last Update Posted:
    Apr 20, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Otitis
    Otitis Externa
    Diclofenac

    Study Results

    No Results Posted as of Apr 20, 2016