Status:
COMPLETED
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a randomised, controlled, multi-centre clinical trial on AS patients. Experimental intervention: continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided...
Detailed Description
Ankylosing spondylitis (AS) is a common chronic inflammatory rheumatic disease with a prevalence of about 0.5%. First symptoms normally occur in young adulthood. Early in its course, AS is dominated b...
Eligibility Criteria
Inclusion
- AS according to mod. New York criteria
- Patients must have radiographic damage (at least one syndesmophyte) of the spine but no complete ankylosis of the cervical and lumbar spine (these are patients at risk for further and more rapid radiographic progression)
- Patients must have active disease at inclusion defined as BASDAI question 2 (related to back pain) \>= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms
Exclusion
- No radiographic damage (syndesmophyte) of the spine at baseline
- Complete ankylosis of the cervical and lumbar spine
- Inactive disease
- Evidence of current or past peptic ulcer
- Current or past coronary heart disease
- Stroke or transient ischemic attack
- Uncontrolled hypertension
- Chronic renal failure (creatinine \> 1.5mg/dl)
- Impaired liver function
- Pregnancy
- Abnormal liver function (2x upper limit of normal)
- Active hepatitis B or C, chronic or acute heart failure (NYHA III or IV) -
- History of HIV infection
- History of neoplastic disease (details please refer to exclusion criteria)
- History of abuse of "hard" drugs or alcoholism
- Concomitant treatment with steroids, TNF-blockers, other DMARDs
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00715091
Start Date
September 1 2008
End Date
December 1 2013
Last Update
August 25 2014
Active Locations (30)
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1
Medizinische Universitätsklinik Innere Medizin
Tübingen, Baden-Wurttemberg, Germany, 1072076
2
Praxis Dr. Jacki
Tübingen, Baden-Wurttemberg, Germany, 72072
3
Praxis Dr. Manger
Bamberg, Bavaria, Germany, 96047
4
Praxis Dr. Ochs
Bayreuth, Bavaria, Germany, 95445