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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01559259
First received: March 19, 2012
Last updated: July 25, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of "meaningful" relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to onset of "first perceptible" relief, confirmed by "meaningful" relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time-weighted sum of pain intensity difference scores (categorical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ] [ Designated as safety issue: No ]
  • Time weighted sum of pain intensity difference score (numerical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ] [ Designated as safety issue: No ]
  • Time-weighted sum of pain relief scores [ Time Frame: 2, 6, 8 and 12 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of relief, as measured by time to treatment failure [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject global evaluation of study medication [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01559259     History of Changes
Other Study ID Numbers: B5061001
Study First Received: March 19, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ibuprofen
acetaminophen
pain
molar extraction

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014