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COMPLETEDNCT02066324

Urine Sample Collection From FOP Patients

The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for pr...

Lead sponsor: Novartis Pharmaceuticals•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

Age

5 - 35 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
•Physically able to provide first-morning urine sample of at least 30 mL
•Able to communicate well with the investigator, to understand and comply with the requirements of the study
•About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function

Exclusion Criteria

•Diagnosis of diabetes
•Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
•Diagnosis of cancer other than nonmelanomatous skin cancer.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 12, 2015Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment25

Start dateNov 2013

Last updatedMar 12, 2015

Condition

Fibrodysplasia Ossificans Progressiva

Locations shown

Novartis Investigative Site

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2015Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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