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Ear Drops for Children With Otitis Media

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00622518
First Posted: February 25, 2008
Last Update Posted: December 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Standard Homeopathic Company
Information provided by:
University of Washington
Results First Submitted: September 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 ]

2.  Secondary:   Side Effects of Therapy   [ Time Frame: 5 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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



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
First Submitted: February 13, 2008
First Posted: February 25, 2008
Results First Submitted: September 28, 2010
Results First Posted: December 2, 2010
Last Update Posted: December 2, 2010