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| Tracking Information | |||||
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| First Received Date ICMJE | March 18, 2008 | ||||
| Last Updated Date | June 10, 2009 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | June 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux [ Time Frame: 2 monthly ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00641264 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety assessments via adverse event recording and physical examinations [ Time Frame: 2 monthly ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life Validation in Laryngitis | ||||
| Official Title ICMJE | Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux. | ||||
| Brief Summary | The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect). |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Laryngopharyngeal Reflux (LPR) | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Completion Date | June 2003 | ||||
| Primary Completion Date | June 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00641264 | ||||
| Responsible Party | Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca | ||||
| Study ID Numbers ICMJE | 294 | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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