Ear Drops for Children With Otitis Media

NCT00622518 | Completed Results DMC

• 2 other identifiers: 33097-B07-9092-B 01
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Otitis Media

Keywords

otitis media; children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Side Effects of Therapy

  5 days

Study Arms (2)

1

ACTIVE COMPARATOR

homeopathic ear drops in addition to standard care for otitis media

Drug: Hyland's earache drops

2

NO INTERVENTION

No ear drops, standard care for otitis

Interventions

Hyland's earache drops DRUG

3-4 drops in affected ear 3 times a day as needed for up to 5 days

1

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presenting to participating clinic with otitis media
• Diagnosed with acute otitis media
• Parents rate symptoms as a "moderate problem" or more

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Standard Homeopathic Company: collaborator

Study Sites (1)

University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: James A. Taylor, MD
• Organization: University of Washington

uncjat@u.washington.edu

206-616-1206

Study Officials

• James A Taylor

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 2, 2010
• Results First Posted: December 2, 2010

Record last verified: 2010-11

Locations

US (1)