Back to resultsStudy Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Novel Ibuprofen
Standard Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Headache
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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".
Pain Relief Rating (PRR)
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
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).
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).
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).
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.
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).
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.
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".
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.
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01077973
Brief Title
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Official Title
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 episodic tension-type headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Title
Treatment C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Novel Ibuprofen
Intervention Description
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Intervention Type
Drug
Intervention Name(s)
Standard Ibuprofen
Intervention Description
Single-dose of standard ibuprofen (400mg) plus placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single-dose of placebo
Primary Outcome Measure Information:
Title
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
Description
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).
Time Frame
0 to 3 hours
Title
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
Description
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.
Time Frame
0 to 3 hours
Secondary Outcome Measure Information:
Title
Time to Onset of Meaningful Relief: Remaining Comparisons
Description
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.
Time Frame
0 to 3 hours
Title
Time to Confirmed First Perceptible Relief
Description
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".
Time Frame
0 to 3 hours
Title
Pain Relief Rating (PRR)
Description
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Time Frame
1, 2, 3 hours
Title
Pain Intensity Difference (PID)
Description
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).
Time Frame
1, 2, 3 hours
Title
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
Description
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).
Time Frame
1, 2, 3 hours
Title
Time-weighted Sum of Pain Intensity Difference (SPID)
Description
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).
Time Frame
0 to 2, 0 to 3 hours
Title
Time-weighted Sum of Pain Relief Rating (TOTPAR)
Description
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.
Time Frame
0 to 2, 0 to 3 hours
Title
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
Description
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).
Time Frame
0 to 2, 0 to 3 hours
Title
Cumulative Percentage of Participants With Meaningful Relief
Description
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.
Time Frame
0.5, 1, 2, 3 hours
Title
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Description
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".
Time Frame
0.5, 1, 2, 3 hours
Title
Time to Treatment Failure
Description
Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.
Time Frame
0 to 3 hours
Title
Cumulative Percentage of Participants With Treatment Failure
Description
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Time Frame
0 to 3 hours
Title
Cumulative Percentage of Participants With Complete Relief
Description
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.
Time Frame
1, 2, 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25526232
Citation
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=AH-09-11&StudyName=Study%20Evaluating%20A%20Novel%20Ibuprofen%20Formulation%20In%20Episodic%20Tension-Type%20Headache
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
We'll reach out to this number within 24 hrs