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4-MONTH MONITORING STUDY TO EVALUATE THE RATE OF NASAL POLYPOSIS IN SUBJECTS WHICH IMPROVED WITH UP TO 4 MONTHS OF TREATMENT WITH MOMETHASONE FUROATE IN NASAL OR PLACEBO AEROSOL IN STUDY P01925

4-MONTH MONITORING STUDY TO EVALUATE THE RATE OF NASAL POLYPOSIS IN SUBJECTS WHICH IMPROVED WITH UP TO 4 MONTHS OF TREATMENT WITH MOMETHASONE FUROATE IN NASAL OR PLACEBO AEROSOL IN STUDY P01925

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-034-02
Enrollment
13
Registered
2002-05-09
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

Nasal spray mometasone furoate Type of group
200 ug Mometasone Furoate in nasal spray will be given and will be followed for 4 months. Group name:PLACEBO Type of group
The placebo will be administered and will be followed for 4 months.

Sponsors

SCHERING PLOUGH RESEARCH INSTITUTE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The subjects must present an improvement with the treatment of the Study PCI 925 and be able to join immediately. The subjects must not have experienced an important change in their clinical history or in the concomitant medication used, which could make the evaluations of this study impossible.

Exclusion criteria

Exclusion criteria: Women who intend to become pregnant or who are pregnant find breastfeeding, or are not using a medically acceptable contraceptive. Subjects who use concomitant medications that motivate their exclusion.

Design outcomes

Primary

MeasureTime frame
Outcome name:Recurrence of the presence of nasal polyposis Measure:The recurrence of nasal polyposis after the treatment of Study P01925 will be evaluated by the change in the size of the polyps and in the congestion score, from the beginning of Study P02573 until the end of Study P02573. Timepoints:4 month—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru

Contacts

Public ContactJorge Timoteo

SCHERING PLOUGH DEL PERU S.A.

jorge.timoteo@spcorp.com710-3653

Outcome results

None listed

Source: REPEC (via WHO ICTRP)