Clinical trial NCT01077973: Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Official title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Headache
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 episodic 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
* A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

Exclusion Criteria:

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders

Primary outcomes:
measure: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
timeFrame: 0 to 3 hours
measure: Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
timeFrame: 0 to 3 hours
Secondary outcomes:
measure: Time to Onset of Meaningful Relief: Remaining Comparisons
timeFrame: 0 to 3 hours
measure: Time to Confirmed First Perceptible Relief
timeFrame: 0 to 3 hours
measure: Pain Relief Rating (PRR)
timeFrame: 1, 2, 3 hours
measure: Pain Intensity Difference (PID)
timeFrame: 1, 2, 3 hours
measure: Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
timeFrame: 1, 2, 3 hours
measure: Time-weighted Sum of Pain Intensity Difference (SPID)
timeFrame: 0 to 2, 0 to 3 hours
measure: Time-weighted Sum of Pain Relief Rating (TOTPAR)
timeFrame: 0 to 2, 0 to 3 hours
measure: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
timeFrame: 0 to 2, 0 to 3 hours
measure: Cumulative Percentage of Participants With Meaningful Relief
timeFrame: 0.5, 1, 2, 3 hours
measure: Cumulative Percentage of Participants With Confirmed First Perceptible Relief
timeFrame: 0.5, 1, 2, 3 hours
measure: Time to Treatment Failure
timeFrame: 0 to 3 hours
measure: Cumulative Percentage of Participants With Treatment Failure
timeFrame: 0 to 3 hours
measure: Cumulative Percentage of Participants With Complete Relief
timeFrame: 1, 2, 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.