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Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

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Organon

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis

Treatments

Drug: Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks
Drug: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242489
0663-007
2005_088

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Enrollment

1,167 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
  • Positive therapeutic effect from prior NSAID therapy.
  • Worsening of symptoms upon withdrawal of prior treatment.
  • With the exception of OA, in otherwise good health

Exclusion criteria

  • Weight no more than 280 pounds (male or female).
  • Recent, sustained use of gastroprotective agents.
  • History of arthroscopy of the affected knee within 6 months prior to study entry.
  • History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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