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Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

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NCT01266161

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Central Texas Oral Surgery Associates
Austin, Texas, 78705 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
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 to 40 years of age

- Subjects who undergo surgical removal of at least two third molars

- One of which must be a partial or full bony mandibular impaction

- Subjects must have at least moderate baseline pain (a score of 2 on the categorical
pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm
visual analog scale-pain severity rating scale (VAS-PSR)

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

- Acute localized dental infection at the time of surgery that could confound the
post-surgical evaluation

- Presence or history of any significant organ disease

- Use of prescription or OTC first generation antihistamines

- Females who are pregnant, lactating or of childbearing potential and not using a
medically approved method to prevent pregnancy

NCT01266161
Pfizer
Completed
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: Ibuprofen 600 mg ER
    One 600 mg caplet dosed at 0, 12, 24 and 36 hours
  • Drug: Placebo
    One placebo caplet dosed at times 0, 12, 24 and 36 hours
  • Experimental: Ibuprofen 600 mg extended release
    Intervention: Drug: Ibuprofen 600 mg ER
  • Placebo Comparator: 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
139
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 16 to 40 years of age
  • Subjects who undergo surgical removal of at least two third molars
  • One of which must be a partial or full bony mandibular impaction
  • Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria:

  • Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
  • Presence or history of any significant organ disease
  • Use of prescription or OTC first generation antihistamines
  • Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy
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
 
 
NCT01266161
B3491001
AK-10-13
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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