Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

NCT01266161

Last updated date
Study Location
Central Texas Oral Surgery Associates
Austin, Texas, 78705, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Official Title  ICMJE A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ibuprofen 600 mg extended release
    Intervention: Drug: Ibuprofen 600 mg ER
  • Placebo Comparator: Placebo
    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: August 13, 2018)
106
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2010)
120
Actual Study Completion Date  ICMJE March 31, 2011
Actual Primary Completion Date March 31, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01266161
Other Study ID Numbers  ICMJE B3491001
AK-10-13 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018

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