Topical Voltaren in Otitis Externa - Full Text View

Sponsor:	Sieff Medical Center
Information provided by:	Sieff Medical Center
ClinicalTrials.gov Identifier:	NCT00523120

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Topical Voltaren as an Alternative Treatment for Otitis Externa

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

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
1: Active Comparator voltaren ophta	Drug: diclofenac sodium topical solution used in ear 5 drops 8 3/day
2: Active Comparator dexotic	Drug: dexotc aural drops

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

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:

Sieff Medical Center This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Ear Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Otitis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Otitis Externa
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2010