Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
This study is currently recruiting participants.
Verified June 2013 by GlaxoSmithKline
Information provided by (Responsible Party):
First received: April 25, 2013
Last updated: June 20, 2013
Last verified: June 2013
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).
Drug: Paracetamol and Caffeine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Sum of pain intensity difference (SPID) of experimental formulation vs placebo [ Time Frame: Baseline to 4 hours post dose ] [ Designated as safety issue: No ]SPID to be calculated as the sum of headache intensity differences at 4 hours post-dose. Pain intensity at each time point will be calculated as difference of pain intensity at baseline with pain intensity at a given time point.
Secondary Outcome Measures:
- SPID of other treatments [ Time Frame: Baseline, 1, 2, 3 and 4 hours post dose ] [ Designated as safety issue: No ]Pain intensity at each time point will be calculated as difference of pain intensity at baseline with pain intensity at a given time point.
- Time to perceptible headache relief [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]This endpoint will be assessed as time when participants achieve pain relief scores (PRS) more than or equal to 1.
- Time to meaningful headache relief [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]This endpoint will be assessed as time when subjects reported a PRS ≥ 2.
- Total pain relief (TOTPAR) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]TOTPAR will be sum of products of PRS at each time point with time interval between any two time points being used.
- Sum of TOTPAR and SPID (SPRID) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]Area under the time-response curve for change in headache intensity and headache relief.
- Global Evaluation of Response to Treatment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Global evaluation of treatment response is to be 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).
- Rate of rescue medication [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Proportion of subjects that took rescue medication over the total number of subjects for a given treatment group.
- Time to rescue medication [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Median time taken by participants who will opt for rescue medication to be determined.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Paracetamol/ Caffeine Caplets
Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered
Drug: Paracetamol and Caffeine
Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
Active Comparator: Ibuprofen Caplets
Two ibuprofen caplets plus two placebo caplets to be administered
Caplets containing 200 mg of ibuprofen
Placebo Comparator: Placebo Caplets
Four placebo caplets to be administered
Matching placebo caplets
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842633
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|United States, Massachusetts|
|PAREXEL International, LLC||Recruiting|
|Waltham, Massachusetts, United States, 02451|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 info@GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 info@GSKClinicalSupportHD@gsk.com|
Sponsors and Collaborators
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|