Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187616
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2005-09-13
Brief Title:
Questioning Patients About Adverse Medical Events
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Questioning Patients About Adverse Medical Events A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None