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Trial record 1 of 1 for:    NCT00631111
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Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

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ClinicalTrials.gov Identifier: NCT00631111
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : August 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE February 28, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date August 10, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
Sum of pain relief and pain intensity difference scores [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
Time to meaningful pain relief [ Time Frame: 8 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Official Title  ICMJE Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: effervescent ibuprofen tablets
  • Drug: effervescent Aspirin plus Vitamin C tablets
  • Drug: ibuprofen tablets
  • Drug: placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2008)
270
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631111
Other Study ID Numbers  ICMJE AI-07-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP