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Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Austin, Texas, 78705 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
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00631111
Pfizer
Completed
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

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Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pain
  • Drug: effervescent ibuprofen tablets
  • Drug: effervescent Aspirin plus Vitamin C tablets
  • Drug: ibuprofen tablets
  • Drug: placebo
  • Experimental: 1
    Intervention: Drug: effervescent ibuprofen tablets
  • Active Comparator: 2
    Intervention: Drug: effervescent Aspirin plus Vitamin C tablets
  • Active Comparator: 3
    Intervention: Drug: ibuprofen tablets
  • Placebo Comparator: 4
    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
270
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion:

  • Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
  • In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
  • Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide

Exclusion:

  • Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
  • Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
  • Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception
Sexes Eligible for Study: All
16 Years to 40 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00631111
AI-07-02
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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