Topical Voltaren in Otitis Externa

Topical Voltaren as an Alternative Treatment for Otitis Externa

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00523120

Enrollment

Registered

2007-08-30

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Externa

Brief 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.

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

Interventions

DRUGdiclofenac sodium

topical solution used in ear 5 drops 8 3/day

DRUGdexotc

aural drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
reducing oral analagestic use	1 week

Secondary

Measure	Time frame
adding an alternative treatment for otitis externa	1 week

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026