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
  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:


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
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: 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:
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 September 30, 2014