Trial record 7 of 8 for: Open Studies | "Tension-Type Headache"
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|