Ibuprofen Sodium Tension Headache Study

NCT01362491

Last updated date
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19145, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnancy or breast-feeding


- Alcohol or substance abuse


- Any serious medical or psychiatric disorder

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Advanced Information
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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: Ibuprofen Sodium
  • Active Comparator: Treatment B
    Intervention: Drug: Standard Ibuprofen
  • Placebo Comparator: Treatment C
    Intervention: Drug: Placebo
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
226
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
225
Actual Study Completion Date  ICMJE March 2012
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362491
Other Study ID Numbers  ICMJE AH-11-16
B3411007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014

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