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Ibuprofen Sodium Tension Headache Study

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19145 United States
Contact
1-800-718-1021
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

NCT01362491
Pfizer
Completed
Ibuprofen Sodium Tension Headache Study

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Ibuprofen Sodium Tension Headache Study
Ibuprofen Sodium Tension Headache Study
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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
  • Experimental: Treatment A
    Intervention: Drug: Ibuprofen Sodium
  • Active Comparator: Treatment B
    Intervention: Drug: Standard Ibuprofen
  • Placebo Comparator: Treatment C
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
March 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01362491
AH-11-16
B3411007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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