Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004288

Enrollment

Registered

1999-10-19

Start date

1996-05-31

Completion date

1999-12-31

Last updated

2005-06-24

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

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis, genetic diseases and dysmorphic syndromes, rare disease

Brief summary

OBJECTIVES: I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.

Detailed description

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.

Interventions

DRUGolsalazine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026