MedTrace Logo

Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study

NCT01229449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2018-09-17

Study results available
· View outcomes & findings →

Summary

The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.

Conditions

  • Post-operative Pain

Interventions

DRUG

Ibuprofen/acetaminophen

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water

DRUG

Ibuprofen/acetaminophen (higher dose)

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water

DRUG

Nurofen Plus®

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water

DRUG

Panadeine® Extra

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water

DRUG

Placebo

Two placebo tablets, single dose taken orally with 300 ml water

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Aptuit

    collaborator INDUSTRY

  • Reckitt Benckiser LLC

    lead INDUSTRY

Principal Investigators

  • Stephen Daniels · Premier Research Group Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01229449 on ClinicalTrials.gov