Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

This study has been completed.

First Received: September 13, 2005 No Changes Posted

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187616

Purpose

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.

Condition
Benign Prostatic Hyperplasia

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Random Sample, Prospective Study
Official Title:	Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	214
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2003

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).

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187616

Locations

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Stephen Bent, MD

University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	STEPAE-001
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00187616 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

adverse events
clinical trial methodology

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 06, 2009