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Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01266161
First received: December 22, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Ibuprofen 600 mg ER
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sum of pain relief and pain intensity difference scores from 0-12 hours after the first dose (SPRID 0-12) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Sum of pain relief and pain intensity difference scores from 8-12 hours after the first dose [ Time Frame: 8-12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sum of pain intensity difference scores 0-12, 8-12, 12-24, 20-24, 0-24, 24-36, 32-36, 36-48, 44-48, and 24-48 hours [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Time to first rescue medication for the first dose [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Percentage of subjects taking rescue medication after the first dose, and overall [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Pain relief (PR) at individual time points up to 12 hours [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Pain intensity difference (PID) socres at individual time points up to 48 hours [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Pain relief combined with pain intensity difference (PRID) socres at individual time points up to 12 hours [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Time-weighted sum of pain relief scores from 0-12 and 8-12 hours (TOTPAR 0-12 and 8-12) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Percentage of subjects taking rescue medication in each dosing interval (except the first dose as noted above) [ Time Frame: 12-48 hours ] [ Designated as safety issue: No ]
  • Amount (number of doses) of rescue medication used (overall and in each dosing interval) [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Time to first perceptible relief confirmed by meaningful relief [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Time to meaningful relief [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Times to rescue medication over the entire study [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Global evaluations at 24 and 48 hours (or at the time of first use of rescue medication during each day) [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen 600 mg extended release Drug: Ibuprofen 600 mg ER
One 600 mg caplet dosed at 0, 12, 24 and 36 hours
Placebo Comparator: Placebo Drug: Placebo
One placebo caplet dosed at times 0, 12, 24 and 36 hours

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266161

Locations
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01266161     History of Changes
Other Study ID Numbers: B3491001, AK-10-13
Study First Received: December 22, 2010
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
dental pain
multiple dose
ibuprofen
third molar extraction

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

ClinicalTrials.gov processed this record on May 19, 2013