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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014