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| ID | Type | Description | Link |
|---|---|---|---|
| RH01649 | Other Identifier | GSK |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol/ Caffeine Caplets | Experimental | Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered |
|
| Ibuprofen Caplets | Active Comparator | Two ibuprofen caplets plus two placebo caplets to be administered |
|
| Placebo Caplets | Placebo Comparator | Four placebo caplets to be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol and Caffeine | Drug | Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 4 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International, LLC | Waltham | Massachusetts | 02451 | United States |
365 participants were enrolled in the study out of which 165 participants were randomized in the study. 200 participants were not randomized for the following reasons: 165 were screening failure, 3 due to Adverse Events (AEs), 7 were lost to follow-up, 19 withdrawals by participant, and 6 due to other reasons.
Participants were recruited at clinical sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol/ Caffeine Caplets | Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water |
| FG001 | Ibuprofen Caplets | Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water |
| FG002 | Placebo Caplets | Participants were administered with four placebo caplets with 8 ounces of water |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Demography data is available for 157 Participants only (safety Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracetamol/ Caffeine Caplets | Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water |
| BG001 | Ibuprofen Caplets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 hours post dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paracetamol/ Caffeine Caplets | Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Enrollment into the trial was terminated after randomization of 62% of the plan resulting in a significant reduction in study power. The originally planned inferential statistics (p-values) were therefore not presented in tables summarizing results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D002110 | Caffeine |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ibuprofen | Drug | Caplets containing 200 mg of ibuprofen |
|
| Placebo | Other | Matching placebo caplets |
|
| From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose |
| Number of Participants With Perceptible Pain Relief | 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. | Baseline up to 4 hours |
| Number of Participants With Meaningful Pain Relief | 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. | 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. | 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. | 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). | 4 hours |
| Rate of Rescue Medication | Number of participants that took rescue medication over the total number of participants for a given treatment group | 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). | 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. | 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. | 1 hour and 2 hour post dose |
| Time to the Use of Rescue Medication. | Time taken by the participants to use the rescue medication | Up to 4 hours |
| Withdrawal by Subject |
|
| Technical issues |
|
Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
| BG002 | Placebo Caplets | Participants were administered with four placebo caplets orally with 8 ounces of water |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Ibuprofen Caplets | Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water |
| OG002 | Placebo Caplets | Participants were administered with four placebo caplets orally with eight ounce of water |
|
|
|
| Secondary | 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). | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose |
|
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| Secondary | Number of Participants With Perceptible Pain Relief | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Number | number of participants | Baseline up to 4 hours |
|
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| Secondary | 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. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Median | Full Range | minutes (min.) | Baseline up to 4 hours |
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| Secondary | Number of Participants With Meaningful Pain Relief | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Number | number of participants | Baseline up to 4 hours |
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| Secondary | Time to Meaningful Headache Relief | Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Median | Full Range | min. | Baseline up to 4 hours |
|
|
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| Secondary | 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. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose |
|
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| Secondary | 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. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose |
|
|
|
| Secondary | 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). | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | 4 hours |
|
|
|
| Secondary | Rate of Rescue Medication | Number of participants that took rescue medication over the total number of participants for a given treatment group | ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment. | Posted | Number | number of participants | 4 hours |
|
|
|
| Secondary | 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). | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min. |
|
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| Secondary | 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. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | score on a scale | 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., |
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| Secondary | 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. | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | Posted | Number | number of participants | 1 hour and 2 hour post dose |
|
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| Secondary | Time to the Use of Rescue Medication. | Time taken by the participants to use the rescue medication | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Minutes | Up to 4 hours |
|
|
|
| 0 |
| 62 |
| 4 |
| 62 |
| EG001 | Ibuprofen Caplets | Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water | 0 | 62 | 3 | 62 |
| EG002 | Placebo Caplets | Participants were administered with four placebo caplets orally with 8 ounce of water | 0 | 33 | 1 | 33 |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA | Systematic Assessment |
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| FEELING JITTERY | General disorders | MedDRA | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PARANASAL SINUS DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Aniline Compounds |
| D000588 | Amines |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| At 3 hour (n=61, 62, 32) |
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| Baseline-3 hour (61, 62, 33) |
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| Baseline-4 hour (59, 59, 33) |
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| At 3 hour (n=61, 62, 32) |
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| At 4 hour (n=59, 59, 33) |
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| At 20 min. |
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| At 25 min. |
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| At 30 min. |
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| At 40 min. |
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| At 50 min. |
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| At 60 min. |
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| At 90 min. |
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| At 120 min. |
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| At 180 min. |
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| At 240 min. |
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| 20 min. |
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| 25 min. |
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| 30 min. |
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| 40 min. |
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| 50 min. |
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| 60 min. |
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| 90 min. |
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| 120 min. |
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| 180 min. |
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| 240 min. |
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| Title | Measurements |
|---|---|
|