Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187616
First received: September 13, 2005
Last updated: NA
Last verified: April 2003
History: No changes posted
  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: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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

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

Keywords provided by University of California, San Francisco:
adverse events
clinical trial methodology

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014