Phase 3
N=200
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01077973 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet — 11.2; 10.8 Units on a scale — p=0.299
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Novel Ibuprofen (Drug); Standard Ibuprofen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet |
11.2; 10.8 | 0.299 |
| PRIMARY Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet |
50.3; 55.5 | 0.193 |
| SECONDARY Time to Onset of Meaningful Relief: Remaining Comparisons |
48.2; 50.3; 55.5 | 0.304 |
| SECONDARY Time to Confirmed First Perceptible Relief |
42.3; 41.7; 43.8 | 0.072 |
| SECONDARY Pain Relief Rating (PRR) |
1.9; 1.9; 1.6; 2.6; 2.5; 2.4 | 0.402 |
| SECONDARY Pain Intensity Difference (PID) |
0.9; 0.9; 0.8; 1.3; 1.3; 1.2 | 0.382 |
| SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference (PRID) |
2.8; 2.8; 2.4; 3.9; 3.7; 3.6 | 0.377 |
| SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID) |
2.2; 2.2; 2.0; 3.8; 3.6; 3.4 | 0.259 |
| SECONDARY Time-weighted Sum of Pain Relief Rating (TOTPAR) |
4.5; 4.4; 4.1; 7.5; 7.2; 6.8 | 0.327 |
| SECONDARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) |
6.7; 6.5; 6.1; 11.2; 10.8; 10.2 | 0.292 |
| SECONDARY Cumulative Percentage of Participants With Meaningful Relief |
14.6; 17.7; 10.0; 65.9; 58.2; 60.0 | 0.672 |
| SECONDARY Cumulative Percentage of Participants With Confirmed First Perceptible Relief |
24.4; 30.4; 28.8; 80.5; 67.1; 72.5 | 0.480 |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Cumulative Percentage of Participants With Treatment Failure |
— | — |
| SECONDARY Cumulative Percentage of Participants With Complete Relief |
2.4; 6.3; 1.3; 17.1; 21.5; 15.0 | 0.355 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01077973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.