Ear Drops for Children With Otitis Media

Acute Otitis Media Clinical Trial

Official title:

Ear Drops for Children With Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622518
• Other study ID #: 33097-B
• Secondary ID: 07-9092-B 01
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: November 4, 2010
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: November 2010
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 11 Years

Eligibility

Inclusion Criteria:

• Presenting to participating clinic with otitis media

• Diagnosed with acute otitis media

• Parents rate symptoms as a "moderate problem" or more

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days

Locations

Country	Name	City	State
United States	University of Washington Medical Center-Roosevelt Pediatric Care Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Standard Homeopathic Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days	No
Secondary	Side Effects of Therapy		5 days	Yes