Back to resultsTopical Voltaren in Otitis Externa
Primary Purpose
Otitis Externa
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
diclofenac sodium
dexotc
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Externa
Eligibility 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
Sites / Locations
- Sieff Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
voltaren ophta
dexotic
Outcomes
Primary Outcome Measures
reducing oral analagestic use
Secondary Outcome Measures
adding an alternative treatment for otitis externa
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523120
Brief Title
Topical Voltaren in Otitis Externa
Official Title
Topical Voltaren as an Alternative Treatment for Otitis Externa
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sieff Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Externa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
voltaren ophta
Arm Title
2
Arm Type
Active Comparator
Arm Description
dexotic
Intervention Type
Drug
Intervention Name(s)
diclofenac sodium
Other Intervention Name(s)
voltaren ophta
Intervention Description
topical solution used in ear 5 drops 8 3/day
Intervention Type
Drug
Intervention Name(s)
dexotc
Other Intervention Name(s)
dexotic
Intervention Description
aural drops
Primary Outcome Measure Information:
Title
reducing oral analagestic use
Time Frame
1 week
Secondary Outcome Measure Information:
Title
adding an alternative treatment for otitis externa
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
victor kizhner, m.d.
Organizational Affiliation
Sieff Medical Center, Safed, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sieff Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.ziv.org.il/
Description
Sieff Medical Center
Learn more about this trial
Topical Voltaren in Otitis Externa
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