Completed
Daily Olsalazine Treatment for Ankylosing Spondylitis
What is being tested
olsalazine
Drug
Who is being recruted
Axial Spondyloarthritis+14
+ Ankylosis
+ Arthritis
From 18 to 65 Years
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: May 1996
Summary
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 1996
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week until the protocol dose is reached. Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue unchanged. Concurrent sulfasalazine is prohibited.
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
4 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Axial SpondyloarthritisAnkylosisArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesSpinal DiseasesSpondylitisPathological Conditions, Signs and SymptomsDisease AttributesSpondylarthritisSpondylarthropathiesSpondylitis, AnkylosingGenetic Diseases, InbornRare Diseases
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets modified New York diagnostic criteria Active disease, i.e., morning stiffness for more than 30 minutes Failed or experienced nonlife-threatening reaction to prior sulfasalazine No significant hematologic, hepatic, or renal disease
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers