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

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NCT02837952

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84106 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
Treatment: Estimated 2 days
Screening: Estimated 24 days
Site Visits
Follow up: visits
Treatment: 1 visits
Screening: 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
NCT02837952
Pfizer
Completed
A Study of Ibuprofen (IBU) 250mg/Acetaminophen (APAP) 500mg In The Treatment Of Post-Surgical Dental Pain

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A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: FDC IBU/APAP 250 mg/500 mg
    FDC IBU/APAP 250 mg/500 mg
  • Drug: Placebo
    Placebo
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
February 1, 2017
February 1, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02837952
B5061004
GEMINI MDDP ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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