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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
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
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  
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 ]

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


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