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rofecoxib

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Mar 18, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment309

FDA Designations

No designations recorded

Clinical trial landscape

rofecoxib · 1 trial · 1 indication

Phase 3 1
NCT00637949Safety of Lumiracoxib in Patients With OsteoarthritisOsteoarthritis
COMPLETED309 Analytics
PHASE3COMPLETED
Safety of Lumiracoxib in Patients With Osteoarthritis
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of at least one of seven predefined gastrointestinal adverse events
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
lumiracoxibDEVICE400 mg once daily, oral over 6 weeks
rofecoxibDRUG25 mg, oral, daily over 6 weeks
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age \>=50 years old * Primary osteoarthritis in hip, hand, knee or spine for at least 3 month * Pain in the target joint of moderate intensity * Written informed consent Exclusion Criteria: * Secondary osteoarthritis * Active upper gastro intestinal tract ulceration * Inflam...

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Frequently asked questions about rofecoxib

What is rofecoxib used for?

Rofecoxib is a small molecule being developed for the treatment of osteoarthritis, a musculoskeletal condition. It is currently in Phase 3 clinical development and is being studied in patients with osteoarthritis.

Who makes rofecoxib?

Rofecoxib is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical trials for osteoarthritis.

What phase is rofecoxib in?

Rofecoxib is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial for osteoarthritis has been completed.

What clinical trials is rofecoxib in?

Rofecoxib has been studied in a Phase 3 clinical trial with the identifier NCT00637949, titled 'Safety of Lumiracoxib in Patients With Osteoarthritis'. This trial enrolled 309 participants and has been completed.

Is rofecoxib the same as lumiracoxib?

Rofecoxib is also known as lumiracoxib. The clinical trial NCT00637949, which studied the drug in patients with osteoarthritis, uses the name lumiracoxib in its title, confirming that the two names refer to the same drug.