Trials / Completed
CompletedNCT00004288
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | olsalazine |
Timeline
- Start date
- 1996-05-01
- Completion
- 1999-12-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004288. Inclusion in this directory is not an endorsement.