Autopsy report · NCT01719601

A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain

“The company decided to cancel this study in conformity with PH FDA Circular 2013-004”

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• Withdrawn before it enrolled anyone.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Withdrawn

Sponsor

Janssen Pharmaceutica

Sponsor type

Industry

Conditions

Moderate to Severe Acute Non-Cancer Pain

Interventions

No intervention

Participants

0

Trials that died the same way

• A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
  “The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required” (71% 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.” (71% match in meaning)
• Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
  “The current PI is leaving the study. Study team is awaiting FDA PI change approval.” (70% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (68% match in meaning)
• Maternal Epidural Steroids and Hyperthemia
  “PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed” (68% 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.