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

A Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single Dose of Fast Release Aspirin 1000 mg and Acetaminophen 1000 mg in Tension Type Headache Pain

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.

Study Overview

• Status: Terminated
• Conditions: Headache
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAY1019036); Drug: Acetaminophen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Acetaminophen; 2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets
Experimental: Arm 1	Drug: Acetylsalicylic acid (Aspirin, BAY1019036); 2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets
Placebo Comparator: Arm 3	Drug: Placebo; 2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to meaningful pain relief (defined as the time when the subject indicates pain relief that is meaningful to the subject)	Up to 2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first perceptible relief	Is defined as the time when the subject presses the first stopwatch	Up to 2 hours post-dose
Time to first perceptible relief confirmed	The subjects would meet this outcome if they answer "yes" when asked directly after stopping the first stopwatch, if they marked a "1" on the relief pain scale or if they stopped the 2nd stop watch.	Up to 2 hours post-dose
Change from baseline in pain intensity score at different time points (on an 11-point Categorical Pain Intensity Scale, 0 = no pain, 10 = severe pain)		At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Pain Relief on 5-point Categorical Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, and 4 = complete relief)		At 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)		Up to 1 hour
Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)		Up to 2 hours
Summed time weighted total pain relief scores over first hour (TOTPAR0-1)		Up to 1 hour
Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)		Up to 2 hours
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)		Up to 1 hour
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)		Up to 2 hours
Time to first intake of rescue medication		Up to 2 hours
Cumulative proportion of subjects taking rescue medication by time point		Up to 2 hours
Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent		At 2 hours post-dose or immediately before the first intake of rescue medication, whichever is earlier
Safety variable will be summarized using descriptive statistic based on adverse events collection		Up to 5 days post-dose

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2012
• Primary Completion (Actual): June 4, 2012
• Study Completion (Actual): June 4, 2012

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Acetaminophen
• Other Study ID Numbers: 15771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No