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Experimental Medication For the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00097708
First received: November 29, 2004
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: September 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Anxiety Disorder
Intervention: Drug: experimental anti-anxiety drug

  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
OROS Alprazolam OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
IR Alprazolam IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
Placebo OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.

Participant Flow:   Overall Study
    OROS Alprazolam   IR Alprazolam   Placebo
STARTED   173   176   162 
Intent-to-Treat (ITT)   165   169   149 
Treated   171   176   160 
COMPLETED   109   120   97 
NOT COMPLETED   64   56   65 



  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
OROS Alprazolam No text entered.
IR Alprazolam No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   OROS Alprazolam   IR Alprazolam   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 165   169   149   483 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.1  (12.00)   38.9  (12.02)   38.5  (11.13)   38.8  (11.72) 
Age, Customized 
[Units: Participants]
       
< 40 years   87   90   91   268 
40 - < 65 years   76   78   58   212 
>=65 years   2   1   0   3 
Gender 
[Units: Participants]
       
Female   95   113   103   311 
Male   70   56   46   172 
Region of Enrollment 
[Units: Participants]
       
United States   165   169   149   483 


  Outcome Measures

1.  Primary:   Change in HAM-A Total Score   [ Time Frame: Baseline to week 8 ]


  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: Grace Wang, MD Director Clinical Development & Medical Monitor
Organization: Jazz Pharmaceuticals, Inc.
phone: 650 - 496 - 3777



ClinicalTrials.gov Identifier: NCT00097708     History of Changes
Other Study ID Numbers: JZP 04-001-01
Study First Received: November 29, 2004
Results First Received: September 14, 2011
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration