A DOUBLE-BLIND EXTENSION OF 6 MONTHS CONTROLLED BY ACTIVE COMPARATOR OF A MULTICENTRIC STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF MK-0663 IN THE TREATMENT OF HEMOPHILICAL ARTHROPATHY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-036-00

Enrollment

Registered

2000-07-10

Start date

2000-09-25

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

Group 1 Type of group

MK-0663 90 mg daily for 26 weeks will be administered Group name:Group 2 Type of group

Rofecoxib 25 mg daily for 26 weeks will be administered.

Eligibility

Inclusion criteria

Inclusion criteria: • The patient completed the base protocol until Visit 5.0 (Treatment Week 6), or completed at least 2 weeks of treatment (until Visit 3.0), and was discontinued due to lack of efficacy. • The patient tolerated the study medication in the base protocol and, according to the opinion of the researcher and the clinical monitor, demonstrated compliance with the study procedures and medication. • The patient understands the study procedures and agrees to participate in the study by signing the informed consent document. • Female patients must demonstrate a level of P-HCG subunit in urine consistent with a non-pregnancy status in Visits 5.0 / 7.0, and agree to abstain from abstinence, or to use a double-barrier contraceptive method ( the couple uses a condom and the patient´s diaphragm, contraceptive sponge, or IUD), throughout the study, and continue for at least 14 days after completing treatment with the study medication.

Exclusion criteria

Exclusion criteria: • The patient experienced and / or was discontinued from the study due to serious or clinically important adverse experiences during the base protocol, as determined by the investigator. • The patient is allergic / hypersensitive to VIOXX (rofecoxib)

Design outcomes

Primary

Measure	Time frame
Outcome name:Global Assessment of the Patient on Arthritic Pain (VAS) Global Assessment of the Patient on the State of Arthropathic Disease (VAS) Global Researchers Assessment of the State of the Arthropathic Disease (Llkert) Measure:Efficacy Timepoints:On Visits 8.0 to 10.0 and on the discontinuation visit	—

Secondary

Measure	Time frame
Outcome name:Adverse events will be recorded in each patients exam on the Forms of Adverse Experiences Case Report Measure:Safety Timepoints:During the whole study	—

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results