Clinical trial NCT01559259: Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Official title: EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: ibuprofen
acetaminophen
pain
molar extraction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 394
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.


Eligibility criteria: Inclusion Criteria:

* Males and females 16 to 40 years of age
* Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth

Exclusion Criteria:

* Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
* Pregnant or breastfeeding females

Primary outcomes:
measure: Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
timeFrame: From 0 hour up to 8 hours post-dose
Secondary outcomes:
measure: Time to Onset of Meaningful Pain Relief
timeFrame: From 0 hour up to 12 hours post-dose
measure: Time to Confirmed First Perceptible Relief
timeFrame: From 0 hour up to 12 hours post-dose
measure: Pain Relief Rating Score (PRR)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Pain Intensity Difference on 4-Point Categorical Scale (PID4)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Pain Intensity Difference on 11-Point Numerical Scale (PID11)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
timeFrame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
measure: Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
timeFrame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
measure: Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
timeFrame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
measure: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
timeFrame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
measure: Cumulative Percentage of Participants With Meaningful Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Cumulative Percentage of Participants With Confirmed First Perceptible Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Time to Treatment Failure
timeFrame: From 0 hour up to 12 hours post-dose
measure: Cumulative Percentage of Participants With Treatment Failure
timeFrame: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
measure: Participant Global Evaluation of Study Medication
timeFrame: 12 hour
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kellstein D, Leyva R. Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.