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

Bayer

Status and phase: Completed; Phase 4

Conditions: Tension-Type Headache; Tension-Type Headache (Episodic); Headache

Treatments: Drug: Placebo; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464983

11220 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,115 participants in 5 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 2

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 3

Active Comparator group

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen

Arm 4

Active Comparator group

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen

Arm 5

Placebo Comparator group

Treatment:

Drug: Placebo