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Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

This study has been terminated.
(Enrollment challenges)
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00637416
First received: March 10, 2008
Last updated: November 29, 2016
Last verified: November 2016
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Dysphonia
Interventions: Drug: Lansoprazole
Other: Placebo

  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
No text entered.

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
Lansoprazole and Dietary Control

Lansoprazole and dietary control

Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months

Placebo and Dietary Control

Dietary control and placebo

Placebo: placebo taken by mouth daily for 3 months


Participant Flow:   Overall Study
    Lansoprazole and Dietary Control   Placebo and Dietary Control
STARTED   4   5 
COMPLETED   3   3 
NOT COMPLETED   1   2 
Lost to Follow-up                1                1 
Unable to take study drug                0                1 



  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
Lansoprazole and Dietary Control

Lansoprazole and dietary control

Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months

Placebo and Dietary Control

Dietary control and placebo

Placebo: placebo taken by mouth daily for 3 months

Total Total of all reporting groups

Baseline Measures
   Lansoprazole and Dietary Control   Placebo and Dietary Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   5   9 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4 100.0%      5 100.0%      9 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      2  40.0%      4  44.4% 
Male      2  50.0%      3  60.0%      5  55.6% 
Region of Enrollment 
[Units: Participants]
     
United States   4   5   9 


  Outcome Measures

1.  Primary:   Change in Condition Over Treatment Period   [ Time Frame: 3 months ]


  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: Director, ENT Clinical Research
Organization: University of Kansas Medical Center
phone: (913) 588-7154
e-mail: ksykes@kumc.edu



Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00637416     History of Changes
Other Study ID Numbers: 10720
Study First Received: March 10, 2008
Results First Received: October 5, 2016
Last Updated: November 29, 2016