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

NCT01552798 | Terminated Phase 3

• 1 other identifier: 15771
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Time to first perceptible relief

  Up to 2 hours post-dose

• Time to first perceptible relief confirmed

  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

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Arm 2

ACTIVE COMPARATOR

Drug: Acetaminophen

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylsalicylic acid (Aspirin, BAY1019036) DRUG

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

Arm 1

Acetaminophen DRUG

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

Arm 2

Placebo DRUG

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

Arm 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Westside Family Medical Center

Kalamazoo, Michigan, 49009, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Aspirin; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 13, 2012
• Study Start: March 12, 2012
• Primary Completion: June 4, 2012
• Study Completion: June 4, 2012
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)