Autopsy report · NCT00486343

Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS

“Slower than anticipated enrollment”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 11 months before it stopped.
• 400 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Critical Therapeutics

Sponsor type

Industry

Conditions

Asthma

Interventions

Zileuton CR; Placebo

Participants

400 (planned, not actual)

Sites

1

Countries

United States

Trials that died the same way

• Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
  “Slower than expected enrollment” (98% match in meaning)
• Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route
  “Slow rate of enrollment” (92% match in meaning)
• Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
  “Slow enrollment” (91% 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.