A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

NCT02863575 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: B3741002MIGMIG II
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.

Conditions

Pain

Keywords

third molar extraction; ibuprofen; ibuprofen/caffeine; post-surgical dental pain

Outcome Measures

Primary Outcomes (1)

• 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

  SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain.

  From 0 to 8 hours post-dose on Day 1

Secondary Outcomes (9)

• 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)

  From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1

• 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)

  From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1

• 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)

  From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1

• 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

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1

• Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose

  0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1

Other Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity

  Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)

• Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs)

  Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)

• Number of Participants With Clinically Significant Vital Signs Abnormalities

  Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)

Study Arms (3)

Ibuprofen/Caffeine

EXPERIMENTAL

Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination

Drug: Ibuprofen/Caffeine

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 400 mg

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

Ibuprofen/Caffeine DRUG

Ibuprofen/Caffeine fixed-dose combination

Ibuprofen/Caffeine

Ibuprofen DRUG

Ibuprofen capsule

Ibuprofen

Placebo DRUG

Placebo treatment

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Caffeine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: October 24, 2017
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: April 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)