- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077973
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
July 13, 2012 updated by: Pfizer
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
|
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
|
Active Comparator: Treatment B
|
Single-dose of standard ibuprofen (400mg) plus placebo
|
Placebo Comparator: Treatment C
|
Single-dose of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
Time Frame: 0 to 3 hours
|
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-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
Time Frame: 0 to 3 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Onset of Meaningful Relief: Remaining Comparisons
Time Frame: 0 to 3 hours
|
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
Time Frame: 0 to 3 hours
|
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
|
Time-weighted Sum of Pain Intensity Difference (SPID)
Time Frame: 0 to 2, 0 to 3 hours
|
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)
Time Frame: 0 to 2, 0 to 3 hours
|
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)
Time Frame: 0 to 2, 0 to 3 hours
|
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
Time Frame: 0.5, 1, 2, 3 hours
|
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
|
Pain Relief Rating (PRR)
Time Frame: 1, 2, 3 hours
|
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)
Time Frame: 1, 2, 3 hours
|
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)
Time Frame: 1, 2, 3 hours
|
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
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Time Frame: 0.5, 1, 2, 3 hours
|
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
Time Frame: 0 to 3 hours
|
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
Time Frame: 0 to 3 hours
|
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
Time Frame: 1, 2, 3 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
February 26, 2010
First Submitted That Met QC Criteria
February 26, 2010
First Posted (Estimate)
March 1, 2010
Study Record Updates
Last Update Posted (Estimate)
August 20, 2012
Last Update Submitted That Met QC Criteria
July 13, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Headache
- Tension-Type Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- AH-09-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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