Topical Voltaren in Otitis Externa

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Sieff Medical Center
ClinicalTrials.gov Identifier:
NCT00523120
First received: August 28, 2007
Last updated: September 17, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Sieff Medical Center:

Primary Outcome Measures:
  • reducing oral analagestic use [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adding an alternative treatment for otitis externa [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Victor Kizhner MD, Sieff Medical
ClinicalTrials.gov Identifier: NCT00523120     History of Changes
Other Study ID Numbers: HP 7-264S
Study First Received: August 28, 2007
Last Updated: September 17, 2009
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis Externa
Otitis
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014