Headache, Tension-TypePhase 2/3NCT01755702
Paracetamol With Caffeine to Treat Episodic Tension Type Headache
A Phase 2/3 study testing Experimental paracetamol + caffeine formulation, ibuprofen marketed formulation and Paracetamol marketed formulation in people with Headache, Tension-Type, run by GlaxoSmithKline at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Tension-Type
- What is being tested?
- Experimental paracetamol + caffeine formulation, ibuprofen marketed formulation and Paracetamol marketed formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2009to Mar 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Biomedical Research Alliance of New York LLC
Lake Success, New York, 11042
Elkind Headache Center
Mount Vernon, New York, 10550
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
International Research Service, Inc.
Port Chester, New York, 10573
Springfield Neurology Associates
Springfield, Massachusetts, 01104
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481
About this study
Official title: A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache
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.
- Conditions
- Headache, Tension-Type
- Being tested
- Placebo, Experimental paracetamol + caffeine formulation, ibuprofen marketed formulation, Paracetamol marketed formulation
- Keywords
- caffeine, paracetamol, tension headache
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Experimental paracetamol + caffeine formulationDrug
experimental paracetamol + caffeine formulation
ibuprofen marketed formulationDrug
ibuprofen marketed formulation
Paracetamol marketed formulationDrug
Paracetamol marketed formulation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| Arm 2 | Active comparator | paracetamol marketed forumulation Receives: Drug: Paracetamol marketed formulation |
| Arm 3 | Active comparator | ibuprofen marketed formulation Receives: Drug: ibuprofen marketed formulation |
| Arm 4 | Experimental | experimental paracetamol + caffeine formulation Receives: Drug: Experimental paracetamol + caffeine formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 hours
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 4 hours
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.
Measured: Baseline to 4 hours
Time to Rescue Medication
Time to rescue medication was evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Headache, Tension-TypeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755702
- Sponsor's protocol ID
- A2260597
- Status last verified
- Nov 2014
- First submitted
- 23 Jun 2011
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache
- ClinicalTrials.gov ID
- NCT01755702
- Acronym / sponsor ID
- A2260597
- Conditions
- Headache, Tension-Type
- Keywords
- caffeine, paracetamol, tension headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: PlaceboPlacebo |
| Arm 2 | Active comparator | Drug: Paracetamol marketed formulationparacetamol marketed forumulation |
| Arm 3 | Active comparator | Drug: ibuprofen marketed formulationibuprofen marketed formulation |
| Arm 4 | Experimental | Drug: Experimental paracetamol + caffeine formulationexperimental paracetamol + caffeine formulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of episodic tension-type headache consistent with all of the following:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Arm 1 |
| Experimental paracetamol + caffeine formulationexperimental paracetamol + caffeine formulation | Drug | Arm 4 |
| ibuprofen marketed formulationibuprofen marketed formulation | Drug | Arm 3 |
| Paracetamol marketed formulationParacetamol marketed formulation | Drug | Arm 2 |
Primary outcome
Time to First Perceptible Headache Relief
Time frame: Baseline to 6 hours
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.
8 secondary outcomes
Headache Relief Scores
Time frame: Baseline to 4 hours
Total Pain Relief (TOTPAR)
Time frame: Baseline to 4 hours
Sum of Pain Intensity Difference (SPID)
Time frame: Baseline to 4 hours
Sum of TOTPAR and SPID (SPRID)
Time frame: Baseline to 4 hours
Time to Rescue Medication
Time frame: Baseline to 6 hours post dose
Number of Participants With Complete Headache Relief
Time frame: Baseline to 2 hours
Headache Severity
Time frame: Baseline to 4 hours
Patients Global Assessment in Response to Treatment
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Experimental paracetamol + caffeine formulation, ibuprofen marketed formulation and Paracetamol marketed formulation in people with Headache, Tension-Type, run by GlaxoSmithKline at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Perceptible Headache Relief (time frame: Baseline to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.