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Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by:
Head and Neck Surgery Associates
ClinicalTrials.gov Identifier:
NCT00215787
First received: September 15, 2005
Last updated: September 21, 2010
Last verified: September 2010
Results First Received: August 10, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Nasal Polyps
Gastroesophageal Reflux
Intervention: Drug: lansoprazole

  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
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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
Lansoprazole Lansoprazole 30mg BID for one year

Participant Flow:   Overall Study
    Lansoprazole  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     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.
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Reporting Groups
  Description
Lansoprazole Lansoprazole 30mg BID for one year

Baseline Measures
    Lansoprazole  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     12  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Presence of Reflux in Patients With Polyposis   [ Time Frame: one year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott Phillips
Organization: Head and Neck Surgery Associates
phone: 317-926-1056
e-mail: sphillips@hnsaonline.com


Publications:

Responsible Party: Scott Phillips MD, Head and Neck Surgery Associates
ClinicalTrials.gov Identifier: NCT00215787     History of Changes
Other Study ID Numbers: 2005-0165
Study First Received: September 15, 2005
Results First Received: August 10, 2010
Last Updated: September 21, 2010
Health Authority: United States: Institutional Review Board