Clinical trial NCT01552798: Efficacy of a Single Dose of Aspirin vs. Acetaminophen in Tension Type 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Headache
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to meaningful pain relief (defined as the time when the subject indicates pain relief that is meaningful to the subject)
timeFrame: Up to 2 hours post-dose
Secondary outcomes:
measure: Time to first perceptible relief
timeFrame: Up to 2 hours post-dose
measure: Time to first perceptible relief confirmed
timeFrame: Up to 2 hours post-dose
measure: 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)
timeFrame: At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
measure: 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)
timeFrame: At 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
measure: Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)
timeFrame: Up to 1 hour
measure: Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)
timeFrame: Up to 2 hours
measure: Summed time weighted total pain relief scores over first hour (TOTPAR0-1)
timeFrame: Up to 1 hour
measure: Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)
timeFrame: Up to 2 hours
measure: Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)
timeFrame: Up to 1 hour
measure: Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)
timeFrame: Up to 2 hours
measure: Time to first intake of rescue medication
timeFrame: Up to 2 hours
measure: Cumulative proportion of subjects taking rescue medication by time point
timeFrame: Up to 2 hours
measure: Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent
timeFrame: At 2 hours post-dose or immediately before the first intake of rescue medication, whichever is earlier
measure: Safety variable will be summarized using descriptive statistic based on adverse events collection
timeFrame: Up to 5 days post-dose
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: