Trial · NCT01842633
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
NCT01842633, Phase 3, Terminated, GlaxoSmithKline; results first posted 2017-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache. Trials, record NCT01842633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01842633
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
- NCT number
- NCT01842633
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 365 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pain
- Interventions
- Paracetamol and Caffeine, Ibuprofen, Placebo
- First posted
- 2013-04-29
- Last updated
- 2017-09-01
- Results first posted
- 2017-07-27
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours | 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). |
| Secondary | Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose | 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). |
| Secondary | Number of Participants With Perceptible Pain Relief | Baseline up to 4 hours | |
| Secondary | Time to Perceptible Headache Relief | Baseline up to 4 hours | Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1. |
| Secondary | Number of Participants With Meaningful Pain Relief | Baseline up to 4 hours | |
| Secondary | Time to Meaningful Headache Relief | Baseline up to 4 hours | Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2. |
| Secondary | Total Pain Relief (TOTPAR) | From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose | 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. |
| Secondary | Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID) | From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose | 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. |
| Secondary | Global Evaluation of Response to Treatment | 4 hours | 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). |
| Secondary | Rate of Rescue Medication | 4 hours | Number of participants that took rescue medication over the total number of participants for a given treatment group |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours | Up to 4 hours post dose | Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | score on a scale | MEAN |
| SECONDARY | Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Perceptible Pain Relief | Baseline up to 4 hours | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | number of participants | NUMBER |
| SECONDARY | Time to Perceptible Headache Relief | Baseline up to 4 hours | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | minutes (min.) | MEDIAN |
| SECONDARY | Number of Participants With Meaningful Pain Relief | Baseline up to 4 hours | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | number of participants | NUMBER |
| SECONDARY | Time to Meaningful Headache Relief | Baseline up to 4 hours | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | min. | MEDIAN |
| SECONDARY | Total Pain Relief (TOTPAR) | From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | score on a scale | MEAN |
| SECONDARY | Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID) | From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | score on a scale | MEAN |
| SECONDARY | Global Evaluation of Response to Treatment | 4 hours | ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment. | score on a scale | MEAN |
| SECONDARY | Rate of Rescue Medication | 4 hours | ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment. | number of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group141
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours | Paracetamol/ Caffeine Caplets | -6.13 | Standard Deviation 2.164 | score on a scale | |
| Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours | Ibuprofen Caplets | -5.78 | Standard Deviation 2.098 | score on a scale | |
| Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours | Placebo Caplets | -5.86 | Standard Deviation 2.339 | score on a scale | |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Paracetamol/ Caffeine Caplets | At 1 hour (n=62, 61, 33) | -0.64 | Standard Deviation 0.488 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Ibuprofen Caplets | At 1 hour (n=62, 61, 33) | -0.56 | Standard Deviation 0.418 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Placebo Caplets | At 1 hour (n=62, 61, 33) | -0.57 | Standard Deviation 0.505 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Paracetamol/ Caffeine Caplets | At 2 hour (n=62, 61, 33) | -2.21 | Standard Deviation 1.106 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Ibuprofen Caplets | At 2 hour (n=62, 61, 33) | -2.02 | Standard Deviation 1.002 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Placebo Caplets | At 2 hour (n=62, 61, 33) | -2.04 | Standard Deviation 1.088 | score on a scale |
| Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours | Paracetamol/ Caffeine Caplets | At 3 hour (n=61, 62, 32) | -4.09 | Standard Deviation 1.524 | score on a scale |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paracetamol/ Caffeine Caplets | 65 | |
| Overall Study | STARTED | Ibuprofen Caplets | 66 | |
| Overall Study | STARTED | Placebo Caplets | 34 | |
| Overall Study | COMPLETED | Paracetamol/ Caffeine Caplets | 62 | |
| Overall Study | COMPLETED | Ibuprofen Caplets | 64 | |
| Overall Study | COMPLETED | Placebo Caplets | 34 | |
| Overall Study | NOT COMPLETED | Paracetamol/ Caffeine Caplets | 3 | |
| Overall Study | NOT COMPLETED | Ibuprofen Caplets | 2 | |
| Overall Study | NOT COMPLETED | Placebo Caplets | 0 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Paracetamol/ Caffeine Caplets | 1 | 62 | |
| other | Dyspepsia | Gastrointestinal disorders | Ibuprofen Caplets | 0 | 62 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo Caplets | 0 | 33 | |
| other | Nasopharyngitis | Infections and infestations | Paracetamol/ Caffeine Caplets | 1 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Ibuprofen Caplets | 0 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Caplets | 0 | 33 | |
| other | VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Paracetamol/ Caffeine Caplets | 1 | 62 | |
| other | VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Ibuprofen Caplets | 0 | 62 | |
| other | VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo Caplets | 0 | 33 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Paracetamol/ Caffeine Caplets | 0 | 62 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paracetamol/ Caffeine Caplets | ||
| Total, all-cause mortality | Ibuprofen Caplets | ||
| Total, all-cause mortality | Placebo Caplets | ||
| Total, other adverse events | Paracetamol/ Caffeine Caplets | 4 | 62 |
| Total, other adverse events | Ibuprofen Caplets | 3 | 62 |
| Total, other adverse events | Placebo Caplets | 1 | 33 |
| Total, serious adverse events | Paracetamol/ Caffeine Caplets | 0 | 62 |
| Total, serious adverse events | Ibuprofen Caplets | 0 | 62 |
| Total, serious adverse events | Placebo Caplets | 0 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01842633
GET https://conductscience.org/api/trials/v1/NCT01842633/results?page=2