Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

Study Overview
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Brief Summary
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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 episodic tension-type headache.

Official Title
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Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache

Conditions
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Pain

Intervention / Treatment
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* Drug: Novel Ibuprofen
* Drug: Standard Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics Exclusion Criteria: Pregnancy or breast-feeding Alcohol or substance abuse Any serious medical or psychiatric disorder History of stomach ulcers, stomach bleed, or other bleeding disorders

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: Novel Ibuprofen<br>* Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo<br>|
| Active Comparator: Treatment B<br> | Drug: Standard Ibuprofen<br>* Single-dose of standard ibuprofen (400mg) plus placebo<br>|
| Placebo Comparator: Treatment C<br> | Drug: Placebo<br>* Single-dose of placebo<br>|

What is the study measuring?
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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 to 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 | 
| 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 | 
| 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 | 
| 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 Confirmed 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 | 
| Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or received 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. | 0 to 3 hours | 
| 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 | 

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