Ear Drops for Children With Otitis Media - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2008

Last Updated Date

March 5, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00622518 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ear Drops for Children With Otitis Media

Official Title ^ICMJE

Ear Drops for Children With Otitis Media

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acute Otitis Media

Intervention ^ICMJE

Drug: Hyland's earache drops

Study Arms / Comparison Groups

Active Comparator: homeopathic ear drops in addition to standard care for otitis media
No Intervention: No ear drops, standard care for otitis

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

March 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00622518

Responsible Party

James A. Taylor, MD, Professor, University of Washington

Study ID Numbers ^ICMJE

33097-B, 07-9092-B 01

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

Standard Homeopathic Company

Investigators ^ICMJE

Principal Investigator:

James A Taylor

University of Washington

Information Provided By

University of Washington

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP