Back to resultsParacetamol With Caffeine to Treat Episodic Tension Type Headache
Primary Purpose
Headache, Tension-Type
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Experimental paracetamol + caffeine formulation
ibuprofen marketed formulation
Paracetamol marketed formulation
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Tension-Type focused on measuring caffeine, paracetamol, tension headache
Eligibility Criteria
Inclusion Criteria:
Diagnosis of episodic tension-type headache consistent with all of the following:
- number of days with the condition is historically greater than or equal to two per month
- onset of condition was greater than or equal to 12 months from Visit 1
- age of onset was < 50 years
- severity of headaches is historically at least moderate
- duration of headaches is historically greater than or equal to four hours, if untreated
- number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
- treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
Exclusion Criteria:
- Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
- If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Sites / Locations
- University Clinical Research, Inc.
- Springfield Neurology Associates
- MedVadis Research Corporation
- Biomedical Research Alliance of New York LLC
- Elkind Headache Center
- International Research Service, Inc.
- Jefferson Headache Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Placebo
paracetamol marketed forumulation
ibuprofen marketed formulation
experimental paracetamol + caffeine formulation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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 to Rescue Medication
Time to rescue medication was evaluated.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01755702
Brief Title
Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Official Title
A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Tension-Type
Keywords
caffeine, paracetamol, tension headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
paracetamol marketed forumulation
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
ibuprofen marketed formulation
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
experimental paracetamol + caffeine formulation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Experimental paracetamol + caffeine formulation
Intervention Description
experimental paracetamol + caffeine formulation
Intervention Type
Drug
Intervention Name(s)
ibuprofen marketed formulation
Intervention Description
ibuprofen marketed formulation
Intervention Type
Drug
Intervention Name(s)
Paracetamol marketed formulation
Intervention Description
Paracetamol marketed formulation
Primary Outcome Measure Information:
Title
Time to First Perceptible Headache Relief
Description
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
Secondary Outcome Measure Information:
Title
Headache Relief Scores
Description
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
Title
Total Pain Relief (TOTPAR)
Description
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
Title
Sum of Pain Intensity Difference (SPID)
Description
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
Title
Sum of TOTPAR and SPID (SPRID)
Description
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
Title
Time to Rescue Medication
Description
Time to rescue medication was evaluated.
Time Frame
Baseline to 6 hours post dose
Title
Number of Participants With Complete Headache Relief
Description
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
Title
Headache Severity
Description
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
Title
Patients Global Assessment in Response to Treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of episodic tension-type headache consistent with all of the following:
number of days with the condition is historically greater than or equal to two per month
onset of condition was greater than or equal to 12 months from Visit 1
age of onset was < 50 years
severity of headaches is historically at least moderate
duration of headaches is historically greater than or equal to four hours, if untreated
number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
Exclusion Criteria:
Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
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
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Springfield Neurology Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Biomedical Research Alliance of New York LLC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Elkind Headache Center
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
International Research Service, Inc.
City
Port Chester
State/Province
New York
ZIP/Postal Code
10573
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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Paracetamol With Caffeine to Treat Episodic Tension Type Headache
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