Trial Outcomes & Findings for Study Comparing the Efficacy of Two Ibuprofen Formulations (NCT NCT00740857)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

211 participants

Primary outcome timeframe

0-6 hours

Results posted on

2011-06-06

Participant Flow

Patients were recruited in the United States from August 2008 to October 2008.

During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient's eligibility. Surgery occurred within 14 days of the screening visit.

Participant milestones

Participant milestones
Measure	Placebo 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery	Ibuprofen Formulation 1 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery	Ibuprofen Formulation 2 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
Overall Study STARTED	33	88	90
Overall Study COMPLETED	32	88	90
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery	Ibuprofen Formulation 1 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery	Ibuprofen Formulation 2 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Study Comparing the Efficacy of Two Ibuprofen Formulations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=33 Participants 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery	Ibuprofen Formulation 1 n=88 Participants 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery	Ibuprofen Formulation 2 n=90 Participants 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery	Total n=211 Participants Total of all reporting groups
Age Continuous	18.8 years STANDARD_DEVIATION 2.7 • n=5 Participants	18.5 years STANDARD_DEVIATION 2.5 • n=7 Participants	19.0 years STANDARD_DEVIATION 3.0 • n=5 Participants	18.8 years STANDARD_DEVIATION 2.7 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	43 Participants n=7 Participants	45 Participants n=5 Participants	104 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	45 Participants n=7 Participants	45 Participants n=5 Participants	107 Participants n=4 Participants

PRIMARY outcome

Timeframe: 0-6 hours

Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.

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.