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Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial
This study has been completed.
Study NCT00187616   Information provided by University of California, San Francisco
First Received: September 13, 2005   No Changes Posted

September 13, 2005
September 13, 2005
April 2002
 
 
 
No Changes Posted
 
 
 
Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial
Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

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.

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).

 
Observational
Screening, Cross-Sectional, Random Sample, Prospective Study
Benign Prostatic Hyperplasia
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
214
April 2003
 

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187616
 
STEPAE-001
University of California, San Francisco
 
Principal Investigator: Stephen Bent, MD University of California, San Francisco
University of California, San Francisco
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP