This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Springfield Neurology Associates
Springfield, Massachusetts, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States
Biomedical Research Alliance of New York LLC
Lake Success, New York, United States
Time to First Perceptible Headache Relief
Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.
Time frame: Baseline to 6 hours
Headache Relief Scores
Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.
Time frame: Baseline to 4 hours
Total Pain Relief (TOTPAR)
TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. It was calculated using the following formula. TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point.
Time frame: Baseline to 4 hours
Sum of Pain Intensity Difference (SPID)
Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint. Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain. It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.
Time frame: Baseline to 4 hours
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Paracetamol marketed formulation
Elkind Headache Center
Mount Vernon, New York, United States
International Research Service, Inc.
Port Chester, New York, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Sum of TOTPAR and SPID (SPRID)
Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID: SPRIDt = TOTPARt + SPIDt TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.
Time frame: Baseline to 4 hours
Time to Rescue Medication
Time to rescue medication was evaluated.
Time frame: Baseline to 6 hours post dose
Number of Participants With Complete Headache Relief
Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.
Time frame: Baseline to 2 hours
Headache Severity
Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point. Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.
Time frame: Baseline to 4 hours
Patients Global Assessment in Response to Treatment
Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.
Time frame: Baseline to 8 weeks