Terminated/Withdrawn

Headache

Bayer Identifier:

15771

ClinicalTrials.gov Identifier:

NCT01552798

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

Trial Dates

March 2012 - June 2012

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Terminated	Westside Family Medical Center	Kalamazoo, 49009, United States

Primary Outcome

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
Safety Issue:
No

Secondary Outcome

Time to first perceptible relief
Is defined as the time when the subject presses the first stopwatch
Time Frame:
Up to 2 hours post-dose
Safety Issue:
No
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.
Time Frame:
Up to 2 hours post-dose
Safety Issue:
No
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
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
Safety Issue:
No
Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)
Time Frame:
Up to 1 hour
Safety Issue:
No
Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)
Time Frame:
Up to 2 hours
Safety Issue:
No
Summed time weighted total pain relief scores over first hour (TOTPAR0-1)
Time Frame:
Up to 1 hour
Safety Issue:
No
Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)
Time Frame:
Up to 2 hours
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
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
Safety Issue:
No
Time to first intake of rescue medication
Time Frame:
Up to 2 hours
Safety Issue:
No
Cumulative proportion of subjects taking rescue medication by time point
Time Frame:
Up to 2 hours
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
Safety Issue:
No
Safety variable will be summarized using descriptive statistic based on adverse events collection
Time Frame:
Up to 5 days post-dose
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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