Back to results

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

Primary Purpose

Headache

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Acetylsalicylic acid (Aspirin, BAY1019036)

Acetaminophen

Placebo

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Westside Family Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Time to meaningful pain relief (defined as the time when the subject indicates pain relief that is meaningful to the subject)

Secondary Outcome Measures

Time to first perceptible relief

Is defined as the time when the subject presses the first stopwatch

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.

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)

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)

Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)

Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)

Summed time weighted total pain relief scores over first hour (TOTPAR0-1)

Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)

Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)

Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)

Time to first intake of rescue medication

Cumulative proportion of subjects taking rescue medication by time point

Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent

Safety variable will be summarized using descriptive statistic based on adverse events collection

Full Information

NCT ID

NCT01552798

First Posted

March 9, 2012

Last Updated

December 17, 2018

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01552798

Brief Title

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

Acronym

Tarot Headache

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Study Start Date

March 12, 2012 (Actual)

Primary Completion Date

June 4, 2012 (Actual)

Study Completion Date

June 4, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAY1019036)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to meaningful pain relief (defined as the time when the subject indicates pain relief that is meaningful to the subject)

Time Frame

Up to 2 hours post-dose

Secondary Outcome Measure Information:

Title

Time to first perceptible relief

Description

Is defined as the time when the subject presses the first stopwatch

Time Frame

Up to 2 hours post-dose

Title

Time to first perceptible relief confirmed

Description

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.

Time Frame

Up to 2 hours post-dose

Title

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)

Time Frame

At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication

Title

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)

Time Frame

At 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication

Title

Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)

Time Frame

Up to 1 hour

Title

Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)

Time Frame

Up to 2 hours

Title

Summed time weighted total pain relief scores over first hour (TOTPAR0-1)

Time Frame

Up to 1 hour

Title

Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)

Time Frame

Up to 2 hours

Title

Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)

Time Frame

Up to 1 hour

Title

Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)

Time Frame

Up to 2 hours

Title

Time to first intake of rescue medication

Time Frame

Up to 2 hours

Title

Cumulative proportion of subjects taking rescue medication by time point

Time Frame

Up to 2 hours

Title

Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent

Time Frame

At 2 hours post-dose or immediately before the first intake of rescue medication, whichever is earlier

Title

Safety variable will be summarized using descriptive statistic based on adverse events collection

Time Frame

Up to 5 days post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

Westside Family Medical Center

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs