Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

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. Identifier: NCT00215787
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 22, 2010
Last Update Posted : September 22, 2010
Information provided by:
Head and Neck Surgery Associates

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Nasal Polyps
Gastroesophageal Reflux
Intervention: Drug: lansoprazole

  Participant Flow

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
Lansoprazole Lansoprazole 30mg BID for one year

Participant Flow:   Overall Study

  Baseline Characteristics

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
Lansoprazole Lansoprazole 30mg BID for one year

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   0 
[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

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

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


Responsible Party: Scott Phillips MD, Head and Neck Surgery Associates Identifier: NCT00215787     History of Changes
Other Study ID Numbers: 2005-0165
First Submitted: September 15, 2005
First Posted: September 22, 2005
Results First Submitted: August 10, 2010
Results First Posted: September 22, 2010
Last Update Posted: September 22, 2010