Autopsy report · NCT00961753

Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

“FDA drug recall on July 30, 2010”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 2 months before it stopped.
• 10 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

OSF Healthcare System

Sponsor type

University, hospital or other

Conditions

Patent Ductus Arteriosus

Interventions

optimized ibuprofen; Standard Ibuprofen

Participants

10

Sites

1

Countries

United States

Trials that died the same way

• Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design
  “This study was closed before accrual due to FDA recall of Medication” (73% match in meaning)
• Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
  “Study Drug was FDA approved Summer 2021” (70% match in meaning)
• DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
  “FDA Clinical Hold as of 12/21/07 due to safety concerns” (63% match in meaning)
• Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
  “Sponsor suspended development of the drug on September 3, 2008.” (60% match in meaning)
• Avelumab With Decitabine as First Line for AML Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy
  “Recent FDA approval of a new drug for the same patient population” (59% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.