Clinical study to evaluate efficacy of new paracetamol formulation compared to ibuprofen in headache
Trial overview
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 hours
Timeframe: Up to 4 hours post dose
Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 hours
Timeframe: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose
Number of Participants With Perceptible Pain Relief
Timeframe: Baseline up to 4 hours
Time to Perceptible Headache Relief
Timeframe: Baseline up to 4 hours
Number of Participants With Meaningful Pain Relief
Timeframe: Baseline up to 4 hours
Time to Meaningful Headache Relief
Timeframe: Baseline up to 4 hours
Total Pain Relief (TOTPAR)
Timeframe: 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)
Timeframe: 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
Timeframe: 4 hours
Rate of Rescue Medication
Timeframe: 4 hours
Change From Baseline in Headache Pain Intensity
Timeframe: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
Headache Relief
Timeframe: 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
Timeframe: 1 hour and 2 hour post dose
Time to the use of rescue medication.
Timeframe: Up to 4 hours
Participation criteria
- Participants in good general health, and with diagnosis of ETTH with following conditions:
- a. number of days with the condition is historically greater than or equal to two per month;
- 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.
- Participants in good general health, and with diagnosis of ETTH with following conditions: a. number of days with the condition is historically greater than or equal to two per month; b. severity of headaches is historically at least moderate; c. duration of headaches is historically more than or equal to 4 hours, if untreated.
- 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 location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.