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STUDY OF 12 WEEKS, RANDOMIZED, CONTROLLED WITH PLACEBO AND ACTIVE COMPARATOR, OF PARALLEL GROUP, DOUBLE BLIND, TO EVALUATE THE SAFETY AND EFFICACY OF 30 MG. OF ETORICOXIB COMPARED WITH 2400 MG OF IBUPROPHENE IN PATIENTS WITH OSTEOARTHRITIS (STUDY 2)

STUDY OF 12 WEEKS, RANDOMIZED, CONTROLLED WITH PLACEBO AND ACTIVE COMPARATOR, OF PARALLEL GROUP, DOUBLE BLIND, TO EVALUATE THE SAFETY AND EFFICACY OF 30 MG. OF ETORICOXIB COMPARED WITH 2400 MG OF IBUPROPHENE IN PATIENTS WITH OSTEOARTHRITIS (STUDY 2)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-026-03
Enrollment
140
Registered
2003-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Etoricoxib 30 mg Type of group
30 mg of etoricoxib will be given once a day for 12 weeks. Group name:Placebo Type of group
Etoricoxib 30 mg placebo will be administered once a day for 12 weeks.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The diagnosis of OA of the knee or hip was confirmed by the criteria of clinical and radiographic admission. Patients also had to demonstrate a clinical response to regular use of either NSAIDs or acetaminophen / paracetamol. The NSAID users had to show a worsening of their OA symptoms, as specified by the exacerbation criteria, after the period of pharmacological rest. Patients previously treated with acetaminophen / paracetamol, but without NSAIDs had to demonstrate a specific level of symptoms in the selection and randomization.

Exclusion criteria

Exclusion criteria: The diagnosis of OA of the knee or hip was confirmed by the criteria of clinical and radiographic admission. Patients also had to demonstrate a clinical response to regular use of either NSAIDs or acetaminophen / paracetamol. The NSAID users had to show a worsening of their OA symptoms, as specified by the exacerbation criteria, after the period of pharmacological rest. Patients previously treated with acetaminophen / paracetamol, but without NSAIDs had to demonstrate a specific level of symptoms in the selection and randomization.

Design outcomes

Primary

MeasureTime frame
Outcome name:WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 Physical Function Sub-scale and Global Assessment of the Condition of the Patient Disease. Measure:WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 Physical Function Sub-scale and Global Assessment of the Condition of the Patient Disease. Timepoints:weeks 12—

Secondary

MeasureTime frame
Outcome name:Rigidity Subscale WOMAC VA 3.0, WOMAC VA 3.0 General Average Score and WOMAC VA 3.0 General Subscale. Measure:Global Evaluation of the Response to Patient Therapy, Global Assessment of the Condition of the Investigators Disease, Rigidity Subscale WOMAC VA 3.0, WOMAC VA 3.0 General Average Score and WOMAC VA 3.0 General Subscale. Timepoints:12 weeks—

Countries

Brazil, Chile, Mexico, Peru, United States, Venezuela

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)