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

NCT ID: NCT01552798

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-12

Study Completion Date

2012-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAY1019036)

Intervention Type DRUG

2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets

Arm 2

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets

Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets

Interventions

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Acetylsalicylic acid (Aspirin, BAY1019036)

2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets

Intervention Type DRUG

Acetaminophen

2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets

Intervention Type DRUG

Placebo

2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Westside Family Medical Center

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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15771

Identifier Type: -

Identifier Source: org_study_id