Autopsy report · NCT03335293

RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.

“Due to FDA constraints on the off label use of the medications we will not be able to conduct this evaluation.”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 4

Sponsor

University of Florida

Sponsor type

University, hospital or other

Conditions

Pregnancy; Cesarean Section

Interventions

100 mcg Epinephrine; normal saline; 200 mcg Epinephrine

Participants

0

Trials that died the same way

• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (70% match in meaning)
• A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma
  “One of the drugs for the study is not commercially available.” (69% match in meaning)
• Exploring the Impact of Two-week Kava on the Metabolism of Nicotine and NNK
  “Terms could not be met with the FDA.” (67% match in meaning)
• Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
  “FDA request as study could not serve as the confirmatory trial.” (66% match in meaning)
• Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
  “The study was not approved by the Italian Medicines Agency (AIFA).” (63% 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.