NCT00523120

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

August 28, 2007

Last Update Submit

April 18, 2016

Conditions

Otitis Externa

Outcome Measures

Primary Outcomes (1)

  • reducing oral analagestic use

    1 week

Secondary Outcomes (1)

  • adding an alternative treatment for otitis externa

    1 week

Study Arms (2)

1

ACTIVE COMPARATOR

voltaren ophta

Drug: diclofenac sodium

2

ACTIVE COMPARATOR

dexotic

Drug: dexotc

Interventions

diclofenac sodiumDRUG

topical solution used in ear 5 drops 8 3/day

Also known as: voltaren ophta
1
dexotcDRUG

aural drops

Also known as: dexotic
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults having otitis externa as single diagnosis mild to moderate

You may not qualify if:

  • Diabetes
  • Children
  • Pregnant women
  • Immune compromise
  • Starting other treatment
  • Moderate to severe otitis externa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sieff Medical Center

Safed, 13100, Israel

Location

Related Links

MeSH Terms

Conditions

Otitis Externa

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • victor kizhner, m.d.

    Sieff Medical Center, Safed, ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Victor Kizhner MD

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IL(1)