Back to resultsClinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
Primary Purpose
Pain
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Paracetamol and Caffeine
Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- PAREXEL International, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Paracetamol/ Caffeine Caplets
Ibuprofen Caplets
Placebo Caplets
Arm Description
Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered
Two ibuprofen caplets plus two placebo caplets to be administered
Four placebo caplets to be administered
Outcomes
Primary Outcome Measures
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
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
Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours
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).
Number of Participants With Perceptible Pain Relief
Time to Perceptible Headache Relief
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
Time to Meaningful Headache Relief
Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.
Total Pain Relief (TOTPAR)
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.
Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)
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
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
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
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
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
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.
Time taken by the participants to use the rescue medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01842633
Brief Title
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
Official Title
A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
March 31, 2015 (Actual)
Study Completion Date
March 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol/ Caffeine Caplets
Arm Type
Experimental
Arm Description
Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered
Arm Title
Ibuprofen Caplets
Arm Type
Active Comparator
Arm Description
Two ibuprofen caplets plus two placebo caplets to be administered
Arm Title
Placebo Caplets
Arm Type
Placebo Comparator
Arm Description
Four placebo caplets to be administered
Intervention Type
Drug
Intervention Name(s)
Paracetamol and Caffeine
Intervention Description
Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Caplets containing 200 mg of ibuprofen
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo caplets
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
Description
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).
Time Frame
Up to 4 hours post dose
Secondary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours
Description
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).
Time Frame
From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose
Title
Number of Participants With Perceptible Pain Relief
Time Frame
Baseline up to 4 hours
Title
Time to Perceptible Headache Relief
Description
Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.
Time Frame
Baseline up to 4 hours
Title
Number of Participants With Meaningful Pain Relief
Time Frame
Baseline up to 4 hours
Title
Time to Meaningful Headache Relief
Description
Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.
Time Frame
Baseline up to 4 hours
Title
Total Pain Relief (TOTPAR)
Description
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.
Time Frame
From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose
Title
Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)
Description
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.
Time Frame
From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose
Title
Global Evaluation of Response to Treatment
Description
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).
Time Frame
4 hours
Title
Rate of Rescue Medication
Description
Number of participants that took rescue medication over the total number of participants for a given treatment group
Time Frame
4 hours
Title
Change From Baseline in Headache Pain Intensity
Description
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).
Time Frame
At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
Title
Headache Relief
Description
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.
Time Frame
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.,
Title
Number of Pain Free Participants
Description
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 Frame
1 hour and 2 hour post dose
Title
Time to the Use of Rescue Medication.
Description
Time taken by the participants to use the rescue medication
Time Frame
Up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
PAREXEL International, LLC
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
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