A Study of Ibuprofen (IBU) 250mg/Acetaminophen (APAP) 500mg In The Treatment Of Post-Surgical Dental Pain

NCT02837952

Last updated date
Study Location
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84106, 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
18-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Males and females 18 years to 40 years of age (inclusive).

2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.

3. In general good health and have no contraindications (known allergies) to the study or rescue medication.

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


1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic, disorder 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:


- Gastrointestinal ulcer or gastrointestinal bleeding;


- Paralytic ileus or other gastrointestinal obstructive disorders;


- Bleeding disorder.
2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID (Non-steroidal Anti- Inflammatory Drug); or to APAP (Acetaminophen), tramadol, other opioids, or to their combinations.


3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Follow up: Estimated 14 days
Screening: Estimated 24 days
Treatment: Estimated 2 days
Site Visits
Follow up: visits
Screening: 1 visits
Treatment: 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Vital signs and measurements
Questionnaire
Urine test
Physical examination

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain
Official Title  ICMJE A Phase 3, Double-blind, Randomized Safety And Efficacy Study Comparing Multiple Administrations Of Ibu 250 Mg/Apap 500 Mg (Administered As Two Tablets Of Ibu/Apap 125 Mg/250 Mg) To Placebo In The Treatment Of Post Surgical Dental Pain In Adult Subjects
Brief Summary This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: FDC IBU/APAP 250 mg/500 mg
    FDC IBU/APAP 250 mg/500 mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg
    FDC IBU/APAP 250 mg/500 mg
    Intervention: Drug: FDC IBU/APAP 250 mg/500 mg
  • Placebo Comparator: Placebo
    Placebo
    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: February 14, 2017)
123
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2016)
112
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Males and females 18 years to 40 years of age (inclusive).
  2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
  3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
  4. In general good health and have no contraindications to the study or rescue medication.

Exclusion Criteria

  1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder 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:

    • Gastrointestinal ulcer or gastrointestinal bleeding;
    • Paralytic ileus or other gastrointestinal obstructive disorders;
    • Bleeding disorder.
  2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
  3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

    .

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 40 Years   (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 NCT02837952
Other Study ID Numbers  ICMJE B5061004
GEMINI MDDP ( Other Identifier: Alias Study Number )
MDDP ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 January 2018

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