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A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621959
First Posted: February 22, 2008
Last Update Posted: January 15, 2015
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.
Information provided by (Responsible Party):
UCB Pharma
Results First Submitted: June 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: levocetirizine dihydrochloride
Drug: 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
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Reporting Groups
  Description
Placebo Matched placebo tablets once daily
LCTZ 5 mg levocetirizine dihydrochloride tablet once daily

Participant Flow:   Overall Study
    Placebo   LCTZ
STARTED   295 [1]   301 
COMPLETED   288   292 
NOT COMPLETED   7   9 
Adverse Event                4                2 
Lack of Efficacy                1                1 
Lost to Follow-up                0                2 
Withdrawal by Subject                1                1 
Other                1                3 
[1] In all 791 subjects have been screened and 596 have been randomized



  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
Placebo Matched placebo tablets once daily
LCTZ 5 mg levocetirizine dihydrochloride tablet once daily
Total Total of all reporting groups

Baseline Measures
   Placebo   LCTZ   Total 
Overall Participants Analyzed 
[Units: Participants]
 295   301   596 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.36  (11.05)   37.02  (11.99)   37.18  (11.52) 
Gender 
[Units: Participants]
     
Female   199   206   405 
Male   96   95   191 
Region of Enrollment 
[Units: Participants]
     
United States   295   301   596 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)   [ Time Frame: Over the total treatment period (14 days) ]

2.  Secondary:   Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score   [ Time Frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00621959     History of Changes
Other Study ID Numbers: A00430
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: January 15, 2015