Questioning Patients About Adverse Medical Events

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.

Completed

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Important dates

Study start: 2002
Study completion: 2003
First posted: Sep 16, 2005
Registry last updated: Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed