Phase 3 N=226 Randomized Quadruple-blind Treatment

Ibuprofen Sodium Tension Headache Study

Pain

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View on ClinicalTrials.gov: NCT01362491 ↗

Enrolled (actual)

226

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet — 9.6; 3.5 units on scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ibuprofen Sodium (Drug); Standard Ibuprofen (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet	9.6; 3.5	<0.001 sig
PRIMARY Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet	40.6; 48.5	0.253
SECONDARY Time to Onset of Meaningful Relief: Remaining Comparisons	40.6; 48.5; NA	<0.001 sig
SECONDARY Time to Confirmed First Perceptible Relief	36.9; 43.6; NA	<0.001 sig
SECONDARY Pain Relief Rating (PRR)	1.5; 1.6; 0.3; 2.3; 2.2; 1.0	<0.001 sig
SECONDARY Pain Intensity Difference (PID)	0.7; 0.7; 0.2; 1.0; 1.0; 0.4	<0.001 sig
SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference (PRID)	2.3; 2.2; 0.5; 3.2; 3.2; 1.4	<0.001 sig
SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID)	1.7; 1.7; 0.5; 3.0; 3.1; 1.0	<0.001 sig
SECONDARY Time-weighted Sum of Pain Relief Rating (TOTPAR)	3.8; 3.8; 1.3; 6.6; 6.6; 2.5	<0.001 sig
SECONDARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)	5.5; 5.5; 1.8; 9.6; 9.8; 3.5	<0.001 sig
SECONDARY Cumulative Percentage of Participants With Meaningful Relief	12.1; 4.5; 0; 71.4; 65.2; 13	0.015 sig
SECONDARY Cumulative Percentage of Participants With First Perceptible Relief	18.7; 7.9; 0; 76.9; 74.2; 15.2	0.002 sig
SECONDARY Duration of Relief	—	—
SECONDARY Cumulative Percentage of Participants With Treatment Failure	0; 0; 0	—
SECONDARY Cumulative Percentage of Participants With Complete Relief	0; 0; 0; 5.5; 4.5; 2.2	0.389

Summary

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache

Eligibility Criteria

Inclusion Criteria

Males and females at least 18 years to 65 years of age
A diagnosis of an episodic tension-type headache, as defined by the International Headache Society

Exclusion Criteria

Pregnancy or breast-feeding
Alcohol or substance abuse
Any serious medical or psychiatric disorder

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Data sourced from ClinicalTrials.gov (NCT01362491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.