Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
1 other identifier
interventional
394
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Apr 2012
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedStudy Start
First participant enrolled
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2012
CompletedResults Posted
Study results publicly available
May 19, 2020
CompletedMay 19, 2020
May 1, 2020
5 months
March 19, 2012
March 12, 2020
May 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
From 0 hour up to 8 hours post-dose
Secondary Outcomes (15)
Time to Onset of Meaningful Pain Relief
From 0 hour up to 12 hours post-dose
Time to Confirmed First Perceptible Relief
From 0 hour up to 12 hours post-dose
Pain Relief Rating Score (PRR)
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
- +10 more secondary outcomes
Study Arms (5)
Ibuprofen/acetaminophen (lower dose)
EXPERIMENTALIbuprofen/acetaminophen (middle dose)
EXPERIMENTALIbuprofen/acetaminophen (high dose)
EXPERIMENTALIbuprofen
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
- Pregnant or breastfeeding females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
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.
PMID: 32506309DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 21, 2012
Study Start
April 10, 2012
Primary Completion
September 13, 2012
Study Completion
September 13, 2012
Last Updated
May 19, 2020
Results First Posted
May 19, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.