Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

Back to Search
Print
Bookmark Trial

NCT01559259

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Jean Brown Research
Salt Lake City, Utah, 84124, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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]

Call Now

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

- Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth

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


- Presence of history of significant hepatic, renal, endocrine, cardiovascular,
neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic
disorder


- Pregnant or breastfeeding females

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

PainAn Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain NCT00976716
  1. Funabashi, Chiba
  2. Ichikawa, Chiba
  3. Matsudo, Chiba
  4. Sagamihara, Kanagawa
  5. Ageo, Saitama
  6. Saitama-shi, Saitama
  7. Edogawaku, Tokyo
  8. Kotoku, Tokyo
  9. Nerimaku, Tokyo
  10. Toshimaku, Tokyo
  11. Kofu, Yamanashi
ALL GENDERS
20 Years+
years
MULTIPLE SITES
PainA Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery NCT00651300
  1. Port Macquarie, New South Wales
  2. Randwick, New South Wales
  3. Westmead, New South Wales
  4. Coopers Plain, Queensland
  5. Townsville, Queensland
  6. Heidelberg, Victoria
  7. Prahran, Victoria
  8. Perth, Western Australia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PainPlacebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia NCT00159640
  1. Warrawong, New South Wales
  2. Westmead, New South Wales
  3. Kippa Ring, Queensland
  4. Maroochydore, Queensland
  5. Bedford Park, South Australia
  6. Perth, Western Australia
  7. Woodville,
  8. Kelowna, British Columbia
  9. Halifax, Nova Scotia
  10. Toronto, Ontario
  11. Sherbrooke, Quebec
  12. Ste-foy, Quebec
  13. Brno,
  14. Ceske Budejovice,
  15. CZ-Praha 8,
  16. Plzen,
  17. Praha 5,
  18. Arnhem,
  19. Breda,
  20. Kampen,
  21. Roosendaal,
  22. Rotterdam,
  23. Stadskanaal,
  24. Barcelona,
  25. Granada,
  26. Madrid,
  27. Malaga,
  28. Sevilla,
  29. Portsmouth, Hants
  30. Northampton, Northants
  31. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PainStudy Comparing the Efficacy of Two Ibuprofen Formulations NCT00740857
  1. Salt Lake City, Utah
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Official Title  ICMJE EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
Brief Summary This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen
    Two caplets of ibuprofen 200 mg
  • Drug: Placebo
    Two caplets of placebo
Study Arms  ICMJE
  • Experimental: Ibuprofen/acetaminophen (lower dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Experimental: Ibuprofen/acetaminophen (middle dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Experimental: Ibuprofen/acetaminophen (high dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
  • 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: September 19, 2012)		394
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2012)		410
Actual Study Completion Date  ICMJE September 13, 2012
Actual Primary Completion Date September 13, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 16 to 40 years of age
  • Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth

Exclusion Criteria:

  • Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
  • Pregnant or breastfeeding females
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 NCT01559259
Other Study ID Numbers  ICMJE B5061001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 May 2020

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