Acute Otitis MediaNCT00622518
Ear Drops for Children With Otitis Media
A study testing Hyland's earache drops in people with Acute Otitis Media, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Hyland's earache drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting to participating clinic with otitis media
- Diagnosed with acute otitis media
- Parents rate symptoms as a "moderate problem" or more
Who cannot join
- Diagnosis of otitis media within preceding 30 days
- Receipt of antibiotics within 2 days
- Perforated ear drum or bullous lesion
- Receipt of homeopathic treatment within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, 98105
About this study
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.
- Conditions
- Acute Otitis Media
- Being tested
- Hyland's earache drops
- Keywords
- otitis media, children
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyland's earache dropsDrug
3-4 drops in affected ear 3 times a day as needed for up to 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | homeopathic ear drops in addition to standard care for otitis media Receives: Drug: Hyland's earache drops |
| 2 | No intervention | No ear drops, standard care for otitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Otitis Media Symptoms
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
Measured: 5 days
Secondary outcomes (1)
Side Effects of Therapy
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Homeopathic Company
- Investigators
- James A Taylor, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622518
- Sponsor's protocol ID
- 33097-B
- Other IDs
- 07-9092-B 01
- Status last verified
- Nov 2010
- First submitted
- 13 Feb 2008
- Last updated
- 2 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ear Drops for Children With Otitis Media
- ClinicalTrials.gov ID
- NCT00622518
- Acronym / sponsor ID
- 33097-B
- Conditions
- Acute Otitis Media
- Keywords
- otitis media, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Standard Homeopathic Company
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Posted 2 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Hyland's earache dropshomeopathic ear drops in addition to standard care for otitis media |
| 2 | No intervention | –No ear drops, standard care for otitis |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presenting to participating clinic with otitis media
- Diagnosed with acute otitis media
- Parents rate symptoms as a "moderate problem" or more
Key exclusion criteria (4 listed)
- Diagnosis of otitis media within preceding 30 days
- Receipt of antibiotics within 2 days
- Perforated ear drum or bullous lesion
- Receipt of homeopathic treatment within 30 days
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 |
|---|---|---|
| Hyland's earache drops3-4 drops in affected ear 3 times a day as needed for up to 5 days | Drug | 1 |
Primary outcome
Resolution of Otitis Media Symptoms
Time frame: 5 days
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
1 secondary outcome
Side Effects of Therapy
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
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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.
James A Taylor principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyland's earache drops in people with Acute Otitis Media, run by University of Washington at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 2010. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resolution of Otitis Media Symptoms (time frame: 5 days). 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 2 Dec 2010.