Questioning Patients About Adverse Medical Events
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT00187616
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 214
Inclusion Criteria
- Male, age > 49, American Urological Association Symptom Index > 8
- Max urine flow rate > 4 and < 15
Exclusion Criteria
- prior prostate cancer or surgery
- use of medications that affect urination
- severe concomitant illness
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States