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Paracetamol

Phase 3

Pain, Postoperative | Small molecule | Pain |Baxter International Inc.|Last Updated: Aug 11, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

Paracetamol · 1 trial · 1 indication

Phase 3 1
NCT00508495Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement PainPain, Postoperative
COMPLETED148 Analytics
PHASE3COMPLETED
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Pain, Postoperative
NCT00508495148
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Study Endpoints

Primary Endpoints

Amount of PCA-administered morphine consumed during first six hours of study drug treatment
6 hours from first (of four) study drug doses
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Test drugEXPERIMENTAL -
Reference drugACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Paracetamol (acetaminophen)DRUGFour 100 mL, 15 min IV infusions at six hour intervals
Paracetamol 1% solutionDRUGFour 100 mL, 15 min IV infusions at six hour intervals
0.9% sodium chloride solutionDRUGFour 100 mL, 15 min IV infusions at six hour intervals
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant. * Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day. Exclusion Criteria: * Another acute or chronic...

Countries:Hungary
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Frequently asked questions about Paracetamol

What is Paracetamol used for in postoperative pain?

Paracetamol is used for the treatment of postoperative pain, specifically pain following surgical procedures such as hip replacement. It is being investigated as an analgesic solution for managing pain in the postoperative setting.

Who makes Paracetamol?

Paracetamol is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical trials to evaluate the efficacy and safety of paracetamol-containing solutions for postoperative pain.

What phase is Paracetamol in?

Paracetamol is in Phase 3 clinical development for postoperative pain. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development.

What clinical trials is Paracetamol in?

Paracetamol has one completed Phase 3 clinical trial, identified as NCT00508495. This trial evaluated the analgesic efficacy, safety, and tolerability of two paracetamol-containing solutions in patients with post-surgical hip replacement pain. The study enrolled 148 participants in Hungary.

Is Paracetamol the same as acetaminophen?

Paracetamol is the international nonproprietary name for the drug also known as acetaminophen in some regions. It is a small molecule analgesic used to treat pain and fever, and is being studied for postoperative pain management.