You are here

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

Last updated on May 9, 2019

FOR MORE INFORMATION
Study Location
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84106 United States
Contact
1-800-718-1021
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
NCT02837952
Pfizer
Completed
A Study of Ibuprofen (IBU) 250mg/Acetaminophen (APAP) 500mg In The Treatment Of Post-Surgical Dental Pain

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
NCT03031938
All Genders
0+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now