Study Comparing the Efficacy of Two Ibuprofen Formulations

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00740857
First received: August 22, 2008
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.


Condition Intervention Phase
Pain
Drug: placebo
Drug: ibuprofen Formulation 1
Drug: ibuprofen Formulation 2
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study Comparing the Efficacy of Two Ibuprofen Formulations

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Time to Meaningful Pain Relief [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.


Secondary Outcome Measures:
  • Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.

  • Pain Relief (PR) Scores at Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.

  • Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
    SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).

  • Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).

  • Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
    SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).

  • Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
    TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)

  • Time to First Perceptible Relief [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.


Enrollment: 211
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
2 placebo gels capsules delivered as a single dose.
Active Comparator: 2 Drug: ibuprofen Formulation 1
2 marketed ibuprofen gels
Active Comparator: 3 Drug: ibuprofen Formulation 2
2 marketed ibuprofen gels

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Outpatients with post-operative pain following surgical extraction of third molars,
  • examined by the attending dentist or physician and medically cleared to participate in the study,
  • in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

  • any serious medical condition,
  • acute localized dental infection at the time of surgery ,
  • females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740857

Locations
United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00740857     History of Changes
Other Study ID Numbers: PV-08-24
Study First Received: August 22, 2008
Results First Received: October 30, 2009
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Dental pain analgesia

Additional relevant MeSH terms:
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 April 22, 2014