Topical Voltaren in Otitis Externa - Full Text View

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

Purpose

voltaren being a 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

Drug Information available for: Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

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

Further study details as provided by 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 ]

Study Start Date:

September 2007

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

Contacts

Contact: victor kizhner, m.d.

+972-544705898

vic466@zahav.net.il

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

Sieff Medical Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	HP 7-264S
Study First Received:	August 28, 2007
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00523120
Health Authority:	Israel: Ministry of Health; United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Diclofenac
Otitis Externa
Ear Diseases

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 16, 2009