Otitis ExternaPhase 2NCT00523120
Topical Voltaren in Otitis Externa
A Phase 2 study testing diclofenac sodium and dexotc in people with Otitis Externa, run by Sieff Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Otitis Externa
- What is being tested?
- diclofenac sodium and dexotc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults having otitis externa as single diagnosis mild to moderate
Who cannot join
- Diabetes
- Children
- Pregnant women
- Immune compromise
- Starting other treatment
- Moderate to severe otitis externa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Voltaren as an Alternative Treatment for Otitis Externa
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.
Read the 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
- Conditions
- Otitis Externa
- Being tested
- diclofenac sodium, dexotc
- Medical subject headings
- Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac sodiumDrug
Also called voltaren ophta
topical solution used in ear 5 drops 8 3/day
dexotcDrug
Also called dexotic
aural drops
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | voltaren ophta Receives: Drug: diclofenac sodium |
| 2 | Active comparator | dexotic Receives: Drug: dexotc |
What is being measured
The primary outcome is the main question the study is designed to answer.
reducing oral analagestic use
Measured: 1 week
Secondary outcomes (1)
adding an alternative treatment for otitis externa
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sieff Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, victor kizhner, Sieff Medical Center
- Investigators
- victor kizhner, m.d., Principal investigator, Sieff Medical Center, Safed, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523120
- Sponsor's protocol ID
- HP 7-264S
- Status last verified
- Apr 2016
- First submitted
- 28 Aug 2007
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Voltaren as an Alternative Treatment for Otitis Externa
- ClinicalTrials.gov ID
- NCT00523120
- Acronym / sponsor ID
- HP 7-264S
- Conditions
- Otitis Externa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sieff Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: diclofenac sodiumvoltaren ophta |
| 2 | Active comparator | Drug: dexotcdexotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults having otitis externa as single diagnosis mild to moderate
Key exclusion criteria (6 listed)
- Diabetes
- Children
- Pregnant women
- Immune compromise
- Starting other treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diclofenac sodiumAlso: voltaren ophtatopical solution used in ear 5 drops 8 3/day | Drug | 1 |
| dexotcAlso: dexoticaural drops | Drug | 2 |
Primary outcome
reducing oral analagestic use
Time frame: 1 week
1 secondary outcome
adding an alternative treatment for otitis externa
Time frame: 1 week
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Sieff Medical CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
victor kizhner, m.d. principal investigator
Sieff Medical Center, Safed, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diclofenac sodium and dexotc in people with Otitis Externa, run by Sieff Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reducing oral analagestic use (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.