Efficacy of a Single Dose of Aspirin vs. Acetaminophen in Tension Type Headache (Tarot Headache)

Bayer

Status and phase

Terminated

Phase 3

Conditions

Headache

Treatments

Drug: Acetaminophen

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01552798

15771

Details and patient eligibility

About

The purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache pain.

Enrollment

9 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy, ambulatory, male and female volunteers ages 18-65 years old
History of an onset of tension type headaches before age 50
Experiencing over the last year ≥ 4 tension type headaches of at least moderate intensity per month and with the majority of headaches lasting greater than three hours, that meet commonly recognized criteria for diagnosis per the International Headache Society
History of response to treatment with over-the-counter (OTC) analgesics
Understand the pain rating scales (as judged by the trial coordinator)
Present with at least moderate headache pain on a 0-10 point numerical rating scale (a score of at least 4 on an 11 point scale ranging from 0 to 10) at the Treatment Visit
Onset of pain within three hours of the Treatment Visit
Confirmation by a physician of acute tension type headache symptoms as described by the International Headache Society diagnostic criteria

Exclusion criteria

History of hypersensitivity to aspirin, salicylates, other NSAIDs, acetaminophen, and similar pharmacological agents or components of the investigational products, including the placebo
Use of any immediate release analgesic/anti-pyretic within four hours or use of any sustained release or long acting analgesic/anti-pyretic within 12 hours proceeding administration of Investigational Product
Presence of symptoms that are consistent with menstrual headache or migraine headache as described by the International Headache Society diagnostic criteria
History of migraine headaches more than once per month
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the trial in the judgment of the Investigator
Current or past history of bleeding disorder(s)
History of gastrointestinal bleeding or perforation, related to previous Nonsteroidal Anti-inflammatory Drugs (NSAID) therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
Recent head or neck trauma (within 2 weeks)
Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug