Study Comparing the Efficacy of Two Ibuprofen Formulations

Wyeth

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: ibuprofen Formulation 1; Drug: ibuprofen Formulation 2; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740857

PV-08-24

Details and patient eligibility

About

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

Enrollment: 211 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Active Comparator group

Treatment:

Drug: ibuprofen Formulation 1

3

Active Comparator group

Treatment:

Drug: ibuprofen Formulation 2