Clinical trial NCT02863575: A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: third molar extraction
ibuprofen
ibuprofen/caffeine
post-surgical dental pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 374
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: An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.

Detailed description: The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to placebo.

Eligibility criteria: Inclusion Criteria:

* Males and females 16 years to 40 years of age (inclusive).
* Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
* Examined by the attending dentist or physician and medically cleared to participate in the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:

  * Bleeding disorder;
  * Gastrointestinal ulcer or gastrointestinal bleeding;
  * Paralytic ileus or other gastrointestinal obstructive disorders.
* Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
* Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.

Primary outcomes:
measure: Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen
timeFrame: From 0 to 8 hours post-dose on Day 1
Secondary outcomes:
measure: Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8)
timeFrame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
measure: Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8)
timeFrame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
measure: Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8)
timeFrame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
measure: Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1
measure: Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1
measure: Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1
measure: Time to Onset of Achieving Meaningful Relief
timeFrame: Up to 8 hours post-dose on Day 1
measure: Time to Onset of First Perceptible Relief
timeFrame: Up to 8 hours post-dose on Day 1
measure: Time to Treatment Failure
timeFrame: Up to 8 hours post dose on Day 1
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
timeFrame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)
measure: Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs)
timeFrame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)
measure: Number of Participants Who Used Concomitant Medications, and Rescue Medications
timeFrame: Day 1
measure: Number of Participants Who Used Medications Prior to This Study
timeFrame: At Screening
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: