Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
- Conditions
- Pain
- Interventions
- Registration Number
- NCT01842633
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 365
-
Participants in good general health, and with diagnosis of ETTH with following conditions:
- number of days with the condition is historically greater than or equal to two per month;
- severity of headaches is historically at least moderate;
- duration of headaches is historically more than or equal to 4 hours, if untreated.
- Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
- Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
- Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracetamol/ Caffeine Caplets Paracetamol and Caffeine Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered Placebo Caplets Placebo Four placebo caplets to be administered Ibuprofen Caplets Ibuprofen Two ibuprofen caplets plus two placebo caplets to be administered
- Primary Outcome Measures
Name Time Method Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours Up to 4 hours post dose SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
- Secondary Outcome Measures
Name Time Method Time to Meaningful Headache Relief Baseline up to 4 hours Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.
Total Pain Relief (TOTPAR) From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.
Number of Participants With Perceptible Pain Relief Baseline up to 4 hours Time to Perceptible Headache Relief Baseline up to 4 hours Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.
Number of Participants With Meaningful Pain Relief Baseline up to 4 hours Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.
The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID) From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.
Global Evaluation of Response to Treatment 4 hours Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral \[neither poor nor good\], 3-good, or 4-very good).
Rate of Rescue Medication 4 hours Number of participants that took rescue medication over the total number of participants for a given treatment group
Change From Baseline in Headache Pain Intensity At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min. Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
Headache Relief At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min., The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.
Number of Pain Free Participants 1 hour and 2 hour post dose Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.
Time to the Use of Rescue Medication. Up to 4 hours Time taken by the participants to use the rescue medication
Trial Locations
- Locations (1)
PAREXEL International, LLC
🇺🇸Waltham, Massachusetts, United States