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Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

NCT00913627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2018-03-22

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Conditions

Interventions

DRUG

ibuprofen

DRUG

ibuprofen

DRUG

naproxen

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-07
Primary Completion
2009-08-01
Completion
2009-08-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913627 on ClinicalTrials.gov