Questioning Patients About Adverse Medical Events

January 22, 2024 updated by: University of California, San Francisco

Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Stephen Bent, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEPAE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Prostatic Hyperplasia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe