Study Comparing the Efficacy of Two Ibuprofen Formulations - Full Text View

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:

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

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 May 22, 2013