Autopsy report · NCT01461005

A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

“FDA reclassified so all 522 studies were stopped,”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Ran for about 5 years before it stopped.
• 1 participant enrolled.
• Results were posted on the registry 3 years 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Paradigm Spine

Sponsor type

Industry

Conditions

Spondylolisthesis; Neurologic Deficits; Kyphosis; Pseudarthrosis

Interventions

Dynamic Stabilization System (DSS)

Participants

1

Sites

1

Countries

United States

Trials that died the same way

• Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
  “The study stopped due to marketing approval by the FDA.” (72% 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” (67% match in meaning)
• Medication Use Among American Indians Adults
  “The study has not been stopped. The study does not qualify as a clinical trial so it was withdrawn from clinicaltrials.gov.” (64% match in meaning)
• Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast Cancer
  “Drug development stopped” (62% match in meaning)
• A Dose Escalation Trial of PR610 Treating Patients With Solid Tumors
  “Study was prematurely discontinued due to unacceptable toxicity.” (62% 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.