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Topical Voltaren in Otitis Externa

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523120
First Posted: August 30, 2007
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
victor kizhner, Sieff Medical Center
  Purpose
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 Intervention Phase
Otitis Externa Drug: diclofenac sodium Drug: dexotc Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by victor kizhner, Sieff Medical Center:

Primary Outcome Measures:
  • reducing oral analagestic use [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • adding an alternative treatment for otitis externa [ Time Frame: 1 week ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
voltaren ophta
Drug: diclofenac sodium
topical solution used in ear 5 drops 8 3/day
Other Name: voltaren ophta
Active Comparator: 2
dexotic
Drug: dexotc
aural drops
Other Name: dexotic

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523120


Locations
Israel
Sieff Medical Center
Safed, Israel, 13100
Sponsors and Collaborators
Sieff Medical Center
Investigators
Principal Investigator: victor kizhner, m.d. Sieff Medical Center, Safed, ISRAEL
  More Information

Additional Information:
Responsible Party: victor kizhner, Victor Kizhner MD, Sieff Medical Center
ClinicalTrials.gov Identifier: NCT00523120     History of Changes
Other Study ID Numbers: HP 7-264S
First Submitted: August 28, 2007
First Posted: August 30, 2007
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action