PainPhase 3NCT01842633
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
A Phase 3 study testing Paracetamol and Caffeine and Ibuprofen in people with Pain, run by GlaxoSmithKline at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Paracetamol and Caffeine and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 31 Mar 2015
- Phase
- Phase 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL International, LLC
Waltham, Massachusetts, 02451
About this study
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
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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and CaffeineDrug
Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
IbuprofenDrug
Caplets containing 200 mg of ibuprofen
PlaceboOther
Matching placebo caplets
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol/ Caffeine Caplets | Experimental | Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered Receives: Drug: Paracetamol and Caffeine |
| Ibuprofen Caplets | Active comparator | Two ibuprofen caplets plus two placebo caplets to be administered Receives: Drug: Ibuprofen |
| Placebo Caplets | Placebo comparator | Four placebo caplets to be administered Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 4 hours post dose
Secondary outcomes (13)
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).
Measured: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose
Number of Participants With Perceptible Pain Relief
Measured: Baseline up to 4 hours
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.
Measured: Baseline up to 4 hours
Number of Participants With Meaningful Pain Relief
Measured: Baseline up to 4 hours
Time to Meaningful Headache Relief
Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.
Measured: Baseline up to 4 hours
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.
Measured: From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour 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.
Measured: From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 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).
Measured: 4 hours
Rate of Rescue Medication
Number of participants that took rescue medication over the total number of participants for a given treatment group
Measured: 4 hours
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).
Measured: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
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.
Measured: 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.,
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.
Measured: 1 hour and 2 hour post dose
Time to the Use of Rescue Medication.
Time taken by the participants to use the rescue medication
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study start1 Apr 2013
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
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 PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 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
- NCT01842633
- Sponsor's protocol ID
- 202172
- Other IDs
- RH01649
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2013
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01842633
- Acronym / sponsor ID
- 202172
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 365 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 27 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol/ Caffeine Caplets | Experimental | Drug: Paracetamol and CaffeineTwo caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered |
| Ibuprofen Caplets | Active comparator | Drug: IbuprofenTwo ibuprofen caplets plus two placebo caplets to be administered |
| Placebo Caplets | Placebo comparator | Other: PlaceboFour placebo caplets to be administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants in good general health, and with diagnosis of ETTH with following conditions:
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Paracetamol and CaffeineCaplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine | Drug | Paracetamol/ Caffeine Caplets |
| IbuprofenCaplets containing 200 mg of ibuprofen | Drug | Ibuprofen Caplets |
| PlaceboMatching placebo caplets | Other | Placebo Caplets |
Primary outcome
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
Time frame: 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).
13 secondary outcomes
Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours
Time frame: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose
Number of Participants With Perceptible Pain Relief
Time frame: Baseline up to 4 hours
Time to Perceptible Headache Relief
Time frame: Baseline up to 4 hours
Number of Participants With Meaningful Pain Relief
Time frame: Baseline up to 4 hours
Time to Meaningful Headache Relief
Time frame: Baseline up to 4 hours
Total Pain Relief (TOTPAR)
Time frame: From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose
Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)
Time frame: From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose
Global Evaluation of Response to Treatment
Time frame: 4 hours
Rate of Rescue Medication
Time frame: 4 hours
Change From Baseline in Headache Pain Intensity
Time frame: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
Headache Relief
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.,
Number of Pain Free Participants
Time frame: 1 hour and 2 hour post dose
Time to the Use of Rescue Medication.
Time frame: Up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol and Caffeine and Ibuprofen in people with Pain, run by GlaxoSmithKline at 1 site 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 4 inclusion and 3 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Jul 2017). 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?
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours (time frame: Up to 4 hours post dose). 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 1 Sep 2017.