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Paracetamol experimental

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 Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

Paracetamol experimental · 1 trial · 1 indication

Phase 3 1
NCT00406679Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental PainPain, Postoperative
COMPLETED135 Analytics
PHASE3COMPLETED
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Pain, PostoperativeUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Paracetamol (acetaminophen) solution experimentalDRUG1 gm IV
paracetamol (acetaminophen) solution commercialDRUG1 gm IV
placeboDRUGequivalent volume IV 0.9% sodium chloride (equivalent volume)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal. * Moderate or severe pain within 4 hours after the completi...

Countries:United Kingdom
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Frequently asked questions about Paracetamol experimental

What is Paracetamol experimental used for?

Paracetamol experimental is an investigational small molecule being studied for the treatment of postoperative pain. It is currently in Phase 3 clinical development and has been evaluated in a completed trial for post-surgical dental pain.

Who makes Paracetamol experimental?

Paracetamol experimental is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX.

What phase is Paracetamol experimental in?

Paracetamol experimental is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Paracetamol experimental in?

Paracetamol experimental has one completed Phase 3 trial, NCT00406679, titled 'Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain'. The trial enrolled 135 participants in the United Kingdom.

Is Paracetamol experimental the same as paracetamol?

Paracetamol experimental is a formulation of paracetamol being investigated for postoperative pain. It is distinct from standard paracetamol products in that it is being studied in a clinical trial setting for a specific indication.