Ear Drops for Children With Otitis Media

This study is ongoing, but not recruiting participants.

First Received: February 13, 2008 Last Updated: March 5, 2009 History of Changes

Sponsors and Collaborators:	University of Washington Standard Homeopathic Company
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00622518

Purpose

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.

Condition	Intervention
Acute Otitis Media	Drug: Hyland's earache drops

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ear Drops for Children With Otitis Media

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Carbamide Carbamide peroxide

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

resolution of otitis media symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

side effects of therapy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator homeopathic ear drops in addition to standard care for otitis media	Drug: Hyland's earache drops 3-4 drops in affected ear 3 times a day as needed for up to 5 days
2: No Intervention No ear drops, standard care for otitis

Eligibility

Ages Eligible for Study:	6 Months to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622518

Locations

United States, Washington
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

University of Washington

Standard Homeopathic Company

Investigators

Principal Investigator:

James A Taylor

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( James A. Taylor, MD, Professor )
Study ID Numbers:	33097-B, 07-9092-B 01
Study First Received:	February 13, 2008
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00622518 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

otitis media
children

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

ClinicalTrials.gov processed this record on September 03, 2009