Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Summary

This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

Timeline

Start

2009-07

Primary completion

2010-03

Completion

2010-03

Outcome

Missed primary endpoint

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

registry analysis (superiority or other test); Paracetamol/Caffeine vs Placebo; p = 0.2840; Hazard Ratio (HR) 1.25 (95% CI 0.83 to 1.90); Cox Proportional Hazard Model NCT01755702 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	—	—
Subject	Caffeine	Small molecule	—	—
Comparator	Ibuprofen	Small molecule	—	—

Indications