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Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (C27)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00703534
First received: June 19, 2008
Last updated: May 20, 2011
Last verified: May 2011
History of Changes
Results First Received: February 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Conditions: GERD
Acid Reflux Disease
Heartburn
Regurgitation
Interventions: Drug: AZD3355
Drug: Placebo
Drug: Gelusil®

  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
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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
  Description
AZD3355 AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Participant Flow:   Overall Study
    AZD3355     Placebo  
STARTED     235     243  
COMPLETED     205     218  
NOT COMPLETED     30     25  
Adverse Event                 14                 3  
Withdrawal by Subject                 8                 7  
Incorrect Enrollment                 6                 6  
Lost to Follow-up                 1                 4  
Severe Non Compliance                 1                 5  



  Baseline Characteristics
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  Outcome Measures

1.  Primary:   Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary   [ Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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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Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Debra Silberg, MD, Director of Clinical Research, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703534     History of Changes
Other Study ID Numbers: D9120C00027
Study First Received: June 19, 2008
Results First Received: February 4, 2011
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board