Autopsy report · NCT01755702

Paracetamol With Caffeine to Treat Episodic Tension Type Headache

“Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 11 months after it had already started.
• Ran for about 8 months before it stopped.
• 66 participants enrolled.
• Results were posted on the registry 5 years after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

GlaxoSmithKline

Sponsor type

Industry

Conditions

Headache, Tension-Type

Interventions

Placebo; Experimental paracetamol + caffeine formulation; ibuprofen marketed formulation; Paracetamol marketed formulation

Participants

66

Sites

7

Countries

United States

Trials that died the same way

• Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
  “The study was terminated due to recruitment challenges” (84% match in meaning)
• ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
  “Study was terminated due to difficulty recruiting subjects and lack of efficacy” (83% match in meaning)
• Early Versus Late Amniotomy Following EAB Cervical Ripening
  “Study was terminated due to difficulties in recruitment” (81% match in meaning)
• Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis
  “Study terminated early due to difficulties in subject recruitment” (80% match in meaning)
• A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
  “Study was terminated early due to prolonged recruitment period.” (78% 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.