Autopsy report · NCT00749099

Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

“No longer required study by FDA for NDA approval.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 5 months after it had already started.
• Ran for about 3 years 5 months before it stopped.
• 11 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Digestive Care, Inc.

Sponsor type

Industry

Conditions

Exocrine Pancreatic Insufficiency

Interventions

pancrelipase; placebo

Participants

11

Trials that died the same way

• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (69% 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.” (68% match in meaning)
• Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
  “The study stopped due to marketing approval by the FDA.” (66% match in meaning)
• The Impact of Intraoperative Methadone on Postoperative Opioid Use
  “The study team will no longer be enrolling patients for this research.” (65% match in meaning)
• Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
  “Data no longer required to meet regulatory requirements.” (65% 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.