Autopsy report · NCT00540839

A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

“Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.”

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• Withdrawn before it enrolled anyone.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Withdrawn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 3

Sponsor

Organon and Co

Sponsor type

Industry

Conditions

Asthma, Bronchial

Interventions

Montelukast sodium; Placebo to montelukast; Fluticasone propionate; Placebo to fluticasone

Participants

0

Trials that died the same way

• RF Ablation of the Trigone for the Treatment of UUI
  “for business planning purposes only, and is not related to any safety or performance issues identified during the study” (70% match in meaning)
• Pre-adolescent Stress and Health Study
  “This study does not qualify as a clinical trial under current NIH guidelines.” (65% match in meaning)
• To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
  “After meeting with the FDA, SPARC concludes a BE study will not be required” (65% match in meaning)
• Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines
  “Published study provided evidence that intervention would provide little effect; study not approved by provider community.” (64% match in meaning)
• Immunomonitoring and Biomarker Research in Patients With Squamous Cell Anal Carcinoma
  “Study not submitted to regulatory authorities” (64% 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.