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Ibuprofen Sodium Tension Headache Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Ibuprofen Sodium (Drug); Standard Ibuprofen (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Clinical Details

Official title: Ibuprofen Sodium Tension Headache Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet

Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet

Secondary outcome:

Time to Onset of Meaningful Relief: Remaining Comparisons

Time to Confirmed First Perceptible Relief

Pain Relief Rating (PRR)

Pain Intensity Difference (PID)

Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

Time-weighted Sum of Pain Intensity Difference (SPID)

Time-weighted Sum of Pain Relief Rating (TOTPAR)

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)

Cumulative Percentage of Participants With Meaningful Relief

Cumulative Percentage of Participants With First Perceptible Relief

Duration of Relief

Cumulative Percentage of Participants With Treatment Failure

Cumulative Percentage of Participants With Complete Relief

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Philadelphia, Pennsylvania 19145, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2011
Last updated: July 29, 2014

Page last updated: August 23, 2015

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