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

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01552798
First received: March 9, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Headache
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
Drug: Acetaminophen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first perceptible relief [ Time Frame: Up to 2 hours post-dose ] [ Designated as safety issue: No ]
    Is defined as the time when the subject presses the first stopwatch

  • Time to first perceptible relief confirmed [ Time Frame: Up to 2 hours post-dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1) [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
  • Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2) [ Time Frame: Up to 2 hours ] [ Designated as safety issue: No ]
  • Summed time weighted total pain relief scores over first hour (TOTPAR0-1) [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
  • Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2) [ Time Frame: Up to 2 hours ] [ Designated as safety issue: No ]
  • Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1) [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
  • Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2) [ Time Frame: Up to 2 hours ] [ Designated as safety issue: No ]
  • Time to first intake of rescue medication [ Time Frame: Up to 2 hours ] [ Designated as safety issue: No ]
  • Cumulative proportion of subjects taking rescue medication by time point [ Time Frame: Up to 2 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety variable will be summarized using descriptive statistic based on adverse events collection [ Time Frame: Up to 5 days post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets
Active Comparator: Arm 2 Drug: Acetaminophen
2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets
Placebo Comparator: Arm 3 Drug: Placebo
2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552798

Locations
United States, Michigan
Kalamazoo, Michigan, United States, 49009
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Medical Affairs, Bayer Healthcare L.L.C., Consumer Care
ClinicalTrials.gov Identifier: NCT01552798     History of Changes
Other Study ID Numbers: 15771
Study First Received: March 9, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Acetaminophen
Aspirin
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014