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| Descriptive Information Fields | |||||
| Brief Title † | Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial | ||||
| Official Title † | Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial | ||||
| Brief Summary | This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects. |
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| Detailed Description | 214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplaisa were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind). |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Screening, Cross-Sectional, Random Sample, Prospective Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Benign Prostatic Hyperplasia | ||||
| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 214 | ||||
| Start Date † | April 2002 | ||||
| Completion Date | April 2003 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00187616 | ||||
| Organization ID | STEPAE-001 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of California, San Francisco | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | April 2003 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | September 13, 2005 | ||||