Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT01077973

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Novel Ibuprofen Drug: Standard Ibuprofen Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Ibuprofen Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

SPRID3: 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 Novel Ibuprofen versus Placebo [ Time Frame: over 3 hours ] [ Designated as safety issue: No ]
Time to onset of "meaningful" relief for the comparison of Novel Ibuprofen tablets versus Standard Ibuprofen tablets [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	200
Study Start Date:	March 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment A	Drug: Novel Ibuprofen Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Active Comparator: Treatment B	Drug: Standard Ibuprofen Single-dose of standard ibuprofen (400mg) plus placebo
Placebo Comparator: Treatment C	Drug: Placebo Single-dose of placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077973

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT01077973 History of Changes
Other Study ID Numbers:	AH-09-11
Study First Received:	February 26, 2010
Last Updated:	November 11, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Headache

Additional relevant MeSH terms:

Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 24, 2012