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effervescent ibuprofen

Phase 3

Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Aug 10, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

effervescent ibuprofen · 1 trial · 1 indication

Phase 3 1
NCT00631111Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental PainPain
COMPLETED270 Analytics
PHASE3COMPLETED
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Sum of pain relief and pain intensity difference scores
8 hours

Secondary Endpoints

Time to meaningful pain relief
8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
effervescent ibuprofen tabletsDRUG -
effervescent Aspirin plus Vitamin C tabletsDRUG -
ibuprofen tabletsDRUG -
placeboDRUG -
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Eligibility Criteria

Age Range16 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: * Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * In general good health with no contraindications to the study medication or rescue medication (tramadol or a...

Countries:United States
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Frequently asked questions about effervescent ibuprofen

What is effervescent ibuprofen used for?

Effervescent ibuprofen is used for the treatment of pain, specifically post-surgical dental pain. It is a small molecule drug being developed by Pfizer, Inc. (PFE). The drug is currently in Phase 3 clinical development and is considered investigational, meaning it has not yet been approved by regulatory authorities.

Who makes effervescent ibuprofen?

Effervescent ibuprofen is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for the treatment of pain, specifically post-surgical dental pain.

What phase is effervescent ibuprofen in?

Effervescent ibuprofen is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied for the treatment of pain, specifically post-surgical dental pain, and is being developed by Pfizer, Inc. (PFE).

What clinical trials is effervescent ibuprofen in?

Effervescent ibuprofen has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT00631111. The trial, titled 'Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain,' enrolled 270 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is effervescent ibuprofen FDA approved?

Effervescent ibuprofen is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The drug is being studied for the treatment of post-surgical dental pain, and its safety and efficacy have not yet been established for regulatory approval. It is being developed by Pfizer, Inc. (PFE).