Autopsy report · NCT00034788

A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

“Slow recruitment; Study did not address safety concern raised by European Medicines Agency”

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 2 months before it stopped.
• 84 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor type

Industry

Conditions

Foot Ulcer; Diabetic Foot; Skin Ulcer; Diabetic Neuropathies

Interventions

Becaplermin

Participants

84

Trials that died the same way

• Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
  “study was stopped after enrolment of about 200 patients for slow recruitment” (69% match in meaning)
• Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
  “Study halted due to low recruitment, unrelated to safety or efficacy reasons” (68% match in meaning)
• Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
  “Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited” (66% match in meaning)
• The Effect of Ovamax on Oocyte Quality
  “The study was stopped prematurely due to low recruitment rate” (66% match in meaning)
• Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
  “Study stopped due to difficulties in patient recruitment” (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.