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Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salt Lake City, Utah, 84124 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
16-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Normal, healthy males and females 16 to 40 years of age

- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual
Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS
PSR) following surgical extraction of two or more third molars, at least one of which
must be a partial or complete bony mandibular impaction

- Use of only the following pre-operative medication(s)/anesthetic(s): topical
benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine)
with or without vasoconstrictor and/or nitrous oxide

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

- Pregnancy or breast-feeding

- Alcohol or substance abuse

- Any serious medical or psychiatric disorder

- History of stomach ulcers, stomach bleed, or other bleeding disorders

- Use of a prescription or over-the-counter (OTC) drug with which administration of
ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen
(APAP); or codeine or any other opioid is contraindicated (including: opioids,
antipsychotics, antianxiety agents, or other central nervous system depressants
[including alcohol])

NCT01216163
Pfizer
Completed
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

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Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: Novel Ibuprofen
    Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
  • Drug: Acetaminophen
    Single-dose of acetaminophen (1000mg)
  • Drug: Placebo
    Single-dose of placebo
  • Experimental: Treatment A
    Intervention: Drug: Novel Ibuprofen
  • Active Comparator: Treatment B
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: Treatment C
    Intervention: Drug: Placebo
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. Epub 2014 Dec 15.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal, healthy males and females 16 to 40 years of age
  • Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
  • Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Alcohol or substance abuse
  • Any serious medical or psychiatric disorder
  • History of stomach ulcers, stomach bleed, or other bleeding disorders
  • Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])
Sexes Eligible for Study: All
16 Years to 40 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01216163
AH-09-14
B3411002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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