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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014