Study Comparing the Efficacy of Two Ibuprofen Formulations

A 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: placebo; Drug: ibuprofen Formulation 1; Drug: ibuprofen Formulation 2

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: ibuprofen Formulation 1; 2 marketed ibuprofen gels
Placebo Comparator: 1	Drug: placebo; 2 placebo gels capsules delivered as a single dose.
Active Comparator: 3	Drug: ibuprofen Formulation 2; 2 marketed ibuprofen gels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Meaningful Pain Relief	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.	0-6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Difference (PID) Scores at Each Individual Time Points	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.	0-6 hours
Pain Relief (PR) Scores at Individual Time Points	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.	0-6 hours
Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours 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).	0-2 and 0-6 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points	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).	0-6 hours
Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours 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).	0-2 and 0-6 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours 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)	0-2 and 0-6 hours
Time to First Perceptible Relief	The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.	0-6 hours

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 22, 2008
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Dental pain analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: PV-08-24