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

Last updated on May 9, 2018

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Study Location
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

- 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
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

- History of stomach ulcers, stomach bleed, or other bleeding disorders

NCT01077973
Pfizer
Completed
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

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Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: Novel Ibuprofen
    Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
  • Drug: Standard Ibuprofen
    Single-dose of standard ibuprofen (400mg) plus placebo
  • Drug: Placebo
    Single-dose of placebo
  • Experimental: Treatment A
    Intervention: Drug: Novel Ibuprofen
  • Active Comparator: Treatment B
    Intervention: Drug: Standard Ibuprofen
  • Placebo Comparator: Treatment C
    Intervention: Drug: Placebo
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. Epub 2014 Dec 15.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2010
October 2010   (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
  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01077973
AH-09-11
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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