Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial - Tabular View

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Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

This study has been completed.

Study NCT00187616. Last updated on September 13, 2005. Information provided by University of California, San Francisco

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Official Title ^†

Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Brief Summary

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.

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).

Study Phase

Study Type ^†

Observational

Study Design ^†

Screening, Cross-Sectional, Random Sample, Prospective Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Benign Prostatic Hyperplasia

Intervention ^†

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

214

Start Date ^†

April 2002

Completion Date

April 2003

Eligibility 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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00187616

Organization ID

STEPAE-001

Secondary IDs ^††

Study Sponsor ^†

University of California, San Francisco

Collaborators ^††

Investigators ^†

Principal Investigator:

Stephen Bent, MD

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

April 2003

First Received Date ^†

September 13, 2005

Last Updated Date

September 13, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.