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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
  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 tension-type headache


Condition Intervention Phase
Pain
 Drug: Ibuprofen Sodium
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: Ibuprofen Sodium Tension Headache Study

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

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 ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Ibuprofen Sodium
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Active Comparator: Treatment B Drug: Standard Ibuprofen
Single-dose of standard ibuprofen tablets (400mg)
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

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Alcohol or substance abuse
  • Any serious medical or psychiatric disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362491

Locations
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19145
Sponsors and Collaborators
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: Pfizer
ClinicalTrials.gov Identifier: NCT01362491     History of Changes
Other Study ID Numbers: AH-11-16, B3411007
Study First Received: May 19, 2011
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 22, 2013