Ear Drops for Children With Otitis Media

This study has been completed.

Sponsor:

Collaborator:

Standard Homeopathic Company

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00622518

First received: February 13, 2008

Last updated: November 4, 2010

Last verified: November 2010

History of Changes

Results First Received: September 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Condition:	Acute Otitis Media
Intervention:	Drug: Hyland's earache drops

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
patients were recruited from 2/4/08 through 2/23/09 at a pediatric primary care clinic at the time of a visit for acute otitis media

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ear Drops Plus Standard Therapy	homeopathic ear drops in addition to standard care for otitis media
Standard Therapy Alone	No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen

Participant Flow: Overall Study

	Ear Drops Plus Standard Therapy	Standard Therapy Alone
STARTED	59	60
COMPLETED	59	60
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Ear Drops Plus Standard Therapy	homeopathic ear drops in addition to standard care for otitis media
Standard Therapy Alone	No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
Total	Total of all reporting groups

Baseline Measures

	Ear Drops Plus Standard Therapy	Standard Therapy Alone	Total
Number of Participants [units: participants]	59	60	119
Age [units: participants]
<=18 years	59	60	119
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	3.6 ± 2.5	3.4 ± 2.4	3.5 ± 2.4
Gender [units: participants]
Female	30	25	55
Male	29	35	64
Region of Enrollment [units: participants]
United States	59	60	119

Outcome Measures

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1. Primary:

Resolution of Otitis Media Symptoms [ Time Frame: 5 days ]

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2. Secondary:

Side Effects of Therapy [ Time Frame: 5 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: James A. Taylor, MD
Organization: University of Washington
phone: 206-616-1206
e-mail: uncjat@u.washington.edu

No publications provided

Responsible Party:	James A. Taylor, MD, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT00622518 History of Changes
Other Study ID Numbers:	33097-B, 07-9092-B 01
Study First Received:	February 13, 2008
Results First Received:	September 28, 2010
Last Updated:	November 4, 2010
Health Authority:	United States: Institutional Review Board

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