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Completed

NCT Number: NCT00740857

Study Comparing the Efficacy of Two Ibuprofen Formulations

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

2 placebo gels capsules delivered as a single dose.

ibuprofen Formulation 1

Drug

2 marketed ibuprofen gels

ibuprofen Formulation 2

Drug

2 marketed ibuprofen gels

Primary outcomes

  1. Time to Meaningful Pain Relief

    Time frame: 0-6 hours

    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 outcomes

  1. Pain Intensity Difference (PID) Scores at Each Individual Time Points

    Time frame: 0-6 hours

    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.

  2. Pain Relief (PR) Scores at Individual Time Points

    Time frame: 0-6 hours

    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.

  3. 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

    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).

  4. Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points

    Time frame: 0-6 hours

    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).

  5. Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours

    Time frame: 0-2 and 0-6 hours

    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).

  6. Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours

    Time frame: 0-2 and 0-6 hours

    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)

  7. Time to First Perceptible Relief

    Time frame: 0-6 hours

    The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Study Comparing the Efficacy of Two Ibuprofen Formulations

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 25, 2008
Registry last updated
Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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