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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559259
First Posted: March 21, 2012
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.

Condition Intervention Phase
Pain Drug: Ibuprofen/acetaminophen Drug: Ibuprofen Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time weighted sum of pain intensity difference scores and pain relief scores from 0-8 hours after dosing [ Time Frame: 8 hours ]

Secondary Outcome Measures:
  • Time to onset of "meaningful" relief [ Time Frame: 12 hours ]
  • Time to onset of "first perceptible" relief, confirmed by "meaningful" relief [ Time Frame: 12 hours ]
  • Pain relief rating scored on a 5-point categorical relief rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Pain intensity difference scored on a 4-point categorical pain severity rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose ]
  • Pain intensity difference scored on the 11-point numerical pain severity rating scale [ Time Frame: 0.25, 05, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Sum of pain relief rating and pain intensity difference score [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Time-weighted sum of pain intensity difference scores (categorical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time weighted sum of pain intensity difference score (numerical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief scores [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief rating scores combined with pain intensity difference scores (categorical scale) [ Time Frame: 2, 6 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "first perceptible" relief comfirmed by "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Duration of relief, as measured by time to treatment failure [ Time Frame: 12 hours ]
  • Cumulative proportion of treatment failures [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Subject global evaluation of study medication [ Time Frame: 12 hours ]

Enrollment: 394
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen/acetaminophen (lower dose) Drug: Ibuprofen/acetaminophen
Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
Experimental: Ibuprofen/acetaminophen (middle dose) Drug: Ibuprofen/acetaminophen
Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
Experimental: Ibuprofen/acetaminophen (high dose) Drug: Ibuprofen/acetaminophen
Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
Active Comparator: Ibuprofen Drug: Ibuprofen
Two caplets of ibuprofen 200 mg
Placebo Comparator: Placebo Drug: Placebo
Two caplets of placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559259


Locations
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01559259     History of Changes
Other Study ID Numbers: B5061001
First Submitted: March 19, 2012
First Posted: March 21, 2012
Last Update Posted: July 30, 2014
Last Verified: July 2014

Keywords provided by Pfizer:
ibuprofen
acetaminophen
pain
molar extraction

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action