Ibuprofen Sodium Tension Headache Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01362491

First received: May 19, 2011

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2011

Last Updated Date

March 14, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

SPRID0-3: Time-weighted sum of pain relief rating scores combined with pain intensity difference scores over the 3 hour post-dose evaluation period for the comparison of Ibuprofen Sodium versus placebo [ Time Frame: over 3 hours ] [ Designated as safety issue: No ]
Time to onset of "meaningful" relief for the comparison of Ibuprofen Sodium tablets versus Ibuprofen tablets [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01362491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All pairwise comparisons other than those tested for primary comparisons will be evaluated for these parameters: [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Time to onset of "meaningful" relief [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
Time to onset of "first perceptible" relief, confirmed by "meaningful" relief [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
Pain Relief Rating (PRR): scored on the 5 point Categorical Pain Relief Rating Scale (0=No relief to 4=Complete relief) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
Pain Intensity Difference (PID): scored on the 4 point Categorical Pain Severity Rating Scale (0=None to 3=Severe) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
The sum of pain relief rating and pain intensity difference scores (PRID) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
Sum of pain intensity difference scores [ Time Frame: over 2 & 3 hours ] [ Designated as safety issue: No ]
Time-weighted sum of pain relief rating scores [ Time Frame: over 2 & 3 hours ] [ Designated as safety issue: No ]
Time-weighted sum of pain relief rating scores combined with pain intensity difference scores [ Time Frame: over 2 & 3 hours ] [ Designated as safety issue: No ]
The cumulative proportion of subjects achieving "meaningful" and "first perceptible" relief (confirmed by "meaningful" relief) [ Time Frame: 0.5, 1, 2 & 3 hours ] [ Designated as safety issue: No ]
Duration of relief, as measured by the time to treatment failure [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
The cumulative proportion of treatment failures [ Time Frame: 1, 2, & 3 hours post-dose ] [ Designated as safety issue: No ]
The cumulative proportion of subjects achieving "complete" relief [ Time Frame: 1, 2, & 3 hours post-dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ibuprofen Sodium Tension Headache Study

Official Title ^ICMJE

Ibuprofen Sodium Tension Headache Study

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 tension-type headache

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Ibuprofen Sodium
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Drug: Standard Ibuprofen
Single-dose of standard ibuprofen tablets (400mg)
Drug: Placebo
Single-dose of placebo

Study Arm (s)

Experimental: Treatment A
Intervention: Drug: Ibuprofen Sodium
Active Comparator: Treatment B
Intervention: Drug: Standard Ibuprofen
Placebo Comparator: Treatment C
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

243

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01362491

Other Study ID Numbers ^ICMJE

AH-11-16, B3411007

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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