Text Size

Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

This study has been terminated.
(Pharmaceutical company purchased by another company and funding was terminated.)
Sponsor:
Information provided by (Responsible Party):
Robert T. Sataloff, MD, American Institute for Voice and Ear Research
ClinicalTrials.gov Identifier:
NCT00369265
First received: August 24, 2006
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
Results First Received: July 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Laryngopharyngeal Reflux
Interventions: Drug: Lansoprazole
Dietary Supplement: Sugar pill

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Inadequate recruitment during this study; therefore, the study was terminated.

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
Sugar Pill Placebo for Lansoprazole twice daily
Lansoprazole Lansoprazole 30 mg twice daily

Participant Flow:   Overall Study
    Sugar Pill     Lansoprazole  
STARTED     4     7  
COMPLETED     0     0  
NOT COMPLETED     4     7  
Study terminated                 4                 7  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Sugar Pill Placebo for Lansoprazole twice daily
Lansoprazole Lansoprazole 30 mg twice daily
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Lansoprazole     Total  
Number of Participants  
[units: participants]
 		  4     7     11  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     4     6     10  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation 		  33.0  ± 11.56     40.1  ± 17.33     37.5  ± 15.83  
Gender  
[units: participants]
 		     
Female     3     6     9  
Male     1     1     2  
Region of Enrollment  
[units: participants]
 		     
United States     4     7     11  



  Outcome Measures

1.  Primary:   Percentage of Participants With Improvement or Resolution of Arytenoid Erythema   [ Time Frame: 6 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
The study was terminated due to inadequate subject recruitment.  


Results Point of Contact:  
Name/Title: Robert T. Sataloff, M.D., D.M.A., FACS
Organization: Philadelphia ENT Associates
phone: 215-545-3322
e-mail: rtsataloff@phillyent.com


Publications:


Responsible Party: Robert T. Sataloff, MD, American Institute for Voice and Ear Research
ClinicalTrials.gov Identifier: NCT00369265     History of Changes
Other Study ID Numbers: 10166
Study First Received: August 24, 2006
Results First Received: July 11, 2012
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board