Ibuprofen Sodium Tension Headache Study

Study Overview
=================
Brief Summary
-----------------
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache

Official Title
-----------------
Ibuprofen Sodium Tension Headache Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ibuprofen Sodium
* Drug: Standard Ibuprofen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females at least 18 years to 65 years of age A diagnosis of an episodic tension-type headache, as defined by the International Headache Society Exclusion Criteria: Pregnancy or breast-feeding Alcohol or substance abuse Any serious medical or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Ibuprofen Sodium<br>* Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)<br>|
| Active Comparator: Treatment B<br> | Drug: Standard Ibuprofen<br>* Single-dose of standard ibuprofen tablets (400mg)<br>|
| Placebo Comparator: Treatment C<br> | Drug: Placebo<br>* Single-dose of placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet | SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0-3 Hours | 
| Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0 to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of Meaningful Relief: Remaining Comparisons | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0 to 3 hours | 
| Time to Confirmed First Perceptible Relief | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful. | 0 to 3 hours | 
| Pain Relief Rating (PRR) | PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | 1, 2 & 3 hours post-dose | 
| Pain Intensity Difference (PID) | PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). | 1, 2 & 3 hours post-dose | 
| Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). | 1, 2 & 3 hours post-dose | 
| Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). | 0 to 2, 0 to 3 hours | 
| Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | 0 to 2, 0 to 3 hours | 
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0 to 2, 0 to 3 hours | 
| Cumulative Percentage of Participants With Meaningful Relief | Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0.5, 1, 2, 3 hours | 
| Cumulative Percentage of Participants With First Perceptible Relief | Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful. | 0.5, 1, 2, 3 hours | 
| Duration of Relief | Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first. | 0 to 3 hours | 
| Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | 1, 2, 3 hours post-dose | 
| Cumulative Percentage of Participants With Complete Relief | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief | 1, 2, & 3 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache