MedTrace Logo

Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

NCT00508495 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2011-08-11

No results posted yet for this study

Summary

The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Conditions

  • Pain, Postoperative

Interventions

DRUG

Paracetamol (acetaminophen)

Four 100 mL, 15 min IV infusions at six hour intervals

DRUG

Paracetamol 1% solution

Four 100 mL, 15 min IV infusions at six hour intervals

DRUG

0.9% sodium chloride solution

Four 100 mL, 15 min IV infusions at six hour intervals

Sponsors & Collaborators

  • MDS Pharma Services

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Keyvan Tadjalli Mehr, MD, MSc · Baxter Deutschland GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Hungary

Study Locations

More Related Trials

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 NCT00508495 on ClinicalTrials.gov