Topical Voltaren in Otitis Externa

Otitis Externa Clinical Trial

Official title:

Topical Voltaren as an Alternative Treatment for Otitis Externa

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523120
• Other study ID #: HP 7-264S
• Status: Terminated
• Phase: Phase 2
• First received: August 28, 2007
• Last updated: April 18, 2016
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2016
• Source: Sieff Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Externa

Intervention

Drug:
• diclofenac sodium
topical solution used in ear 5 drops 8 3/day
• dexotc
aural drops

Locations

Country	Name	City	State
Israel	Sieff Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Sieff Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reducing oral analagestic use		1 week	Yes
Secondary	adding an alternative treatment for otitis externa		1 week	Yes

External Links

•   Sieff Medical Center