Topical Voltaren in Otitis Externa

NCT ID: NCT00523120

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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

Conditions

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Otitis Externa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

voltaren ophta

Group Type ACTIVE_COMPARATOR

diclofenac sodium

Intervention Type DRUG

topical solution used in ear 5 drops 8 3/day

2

dexotic

Group Type ACTIVE_COMPARATOR

dexotc

Intervention Type DRUG

aural drops

Interventions

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diclofenac sodium

topical solution used in ear 5 drops 8 3/day

Intervention Type DRUG

dexotc

aural drops

Intervention Type DRUG

Other Intervention Names

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voltaren ophta dexotic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sieff Medical Center

OTHER

Sponsor Role lead

Responsible Party

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victor kizhner

Victor Kizhner MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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victor kizhner, m.d.

Role: PRINCIPAL_INVESTIGATOR

Sieff Medical Center, Safed, ISRAEL

Locations

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Sieff Medical Center

Safed, , Israel

Site Status

Countries

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Israel

Related Links

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http://www.ziv.org.il/

Sieff Medical Center

Other Identifiers

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HP 7-264S

Identifier Type: -

Identifier Source: org_study_id

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