Clinical trial NCT01266161: Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Official title: A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: dental pain
multiple dose
ibuprofen
third molar extraction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 106
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: The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.


Eligibility criteria: Inclusion Criteria:

* Males and females 16 to 40 years of age
* Subjects who undergo surgical removal of at least two third molars
* One of which must be a partial or full bony mandibular impaction
* Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria:

* Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
* Presence or history of any significant organ disease
* Use of prescription or OTC first generation antihistamines
* Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy

Primary outcomes:
measure: Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)
timeFrame: Baseline to 12 hours
measure: Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose
timeFrame: 8 to 12 hours
Secondary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference (SPID) Scores
timeFrame: 0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours
measure: Time to First Dose of Rescue Medication After First Dose of Study Drug
timeFrame: Baseline to 12 hours
measure: Percentage of Participants Taking Rescue Medication
timeFrame: Baseline to 48 hours
measure: Pain Relief (PR) Scores
timeFrame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours
measure: Pain Intensity Difference (PID) Scores
timeFrame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours
measure: Pain Relief Combined With Pain Intensity (PRID) Scores
timeFrame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours
measure: Time-weighted Sum of Pain Relief Scores (TOTPAR)
timeFrame: 0-12 hours, 8-12 hours
measure: Number of Doses of Rescue Medication Used
timeFrame: 0-12, 12-24, 24-36, 36-48, 0-48 hours
measure: Time to Confirmed First Perceptible Relief
timeFrame: Baseline to 12 hours
measure: Time to Meaningful Relief
timeFrame: Baseline to 12 hours
measure: Participant Global Evaluation Score
timeFrame: 24 and 48 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Central Texas Oral Surgery Associates
state: Texas
city: Austin
country: United States
facility: Premier Research
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: