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Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01464983
First received: May 17, 2011
Last updated: November 7, 2011
Last verified: November 2011

May 17, 2011
November 7, 2011
January 2004
Not Provided
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01464983 on ClinicalTrials.gov Archive Site
  • Headache pain relief measured serially on a categorical scale [ Time Frame: Until 4 hours post dose ] [ Designated as safety issue: No ]
  • Measuring the functional ability on conducting everydays activity on a 4 point categorical scale [ Time Frame: 2 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Global assessment of pain therapy [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
  • Safety - assessment of adverse events [ Time Frame: Up to 10 weeks after screening ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache

The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Headache
  • Tension-Type Headache
  • Tension-Type Headache (Episodic)
  • Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
    Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
  • Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
    Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
  • Drug: Ibuprofen
    Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
  • Drug: Ibuprofen
    Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
  • Drug: Placebo
    2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
  • Active Comparator: Arm 1
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
  • Experimental: Arm 2
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
  • Active Comparator: Arm 3
    Intervention: Drug: Ibuprofen
  • Active Comparator: Arm 4
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1065
August 2004
Not Provided

Inclusion Criteria:

  • Ambulatory male or female, 18 to 65 years of age
  • Normal blood pressure
  • Patients suffering from episodic tension-type headache
  • Headache lasting from 30 minutes to 7 days
  • Headache had at least two of the following characteristics:

Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.

- Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.

Exclusion Criteria:

  • Other headaches, including migraine, that required medical treatment
  • Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
  • Mental illness, including depression
  • Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
  • Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
  • Participating in any other clinical study or had done within the previous 4 weeks
  • Had been previously enrolled in this study
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01464983
11220
No
Therapeutic Area Head, Bayer Consumer Care, Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2011

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