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

NCT02863575

Last updated date
Study Location
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ibuprofen/Caffeine
    Ibuprofen/Caffeine fixed-dose combination
  • Drug: Ibuprofen
    Ibuprofen capsule
  • Drug: Placebo
    Placebo treatment
Study Arms  ICMJE
  • Experimental: Ibuprofen/Caffeine
    Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination
    Intervention: Drug: Ibuprofen/Caffeine
  • Active Comparator: Ibuprofen
    Ibuprofen 400 mg
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
374
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
385
Actual Study Completion Date  ICMJE April 6, 2018
Actual Primary Completion Date April 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02863575
Other Study ID Numbers  ICMJE B3741002
MIG ( Other Identifier: Alias Study Number )
MIG II ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP