Autopsy report · NCT00443040

Asimadoline for the Treatment of Post-Operative Ileus

“poor enrollment (31 of a planned 114 subjects were randomized and evaluable)”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Ran for about 1 year 1 month before it stopped.
• 35 participants enrolled.
• Results were posted on the registry 3 years 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Tioga Pharmaceuticals

Sponsor type

Industry

Conditions

Post-Operative Ileus

Interventions

Asimadoline; Placebo

Participants

35

Sites

4

Countries

United States

Trials that died the same way

• Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
  “Low enrollment of qualified subjects” (73% match in meaning)
• Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
  “Poor enrollment” (70% match in meaning)
• Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
  “Poor enrolment; only 6 subjects enrolled and they were all screen failures.” (70% match in meaning)
• Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
  “Failure to enroll a suitable number of qualified subjects.” (70% match in meaning)
• Use of Prokinetics in Early Enteral Feeding in Preterm Infants
  “very poor enrollment” (70% 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.