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Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187616
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Francisco
  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
Time Perspective: Prospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00187616     History of Changes
Other Study ID Numbers: STEPAE-001
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
Last Verified: April 2003

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

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