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Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis

NCT00715091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-08-25

No results posted yet for this study

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 into 75mg Voltaren twice dailyControl intervention: treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment strategy of the control intervention (on-demand) reflects current clinical practice in AS. Duration of intervention per patient: 2 years Follow-up per patient: safety assessment 3 months after termination of the trial.

Conditions

Interventions

DRUG

diclophenac

continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily

DRUG

diclophenac

treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Martin Rudwaleit, MD · Charité University, Berlin, Germany

  • Joachim Sieper, MD · Charité University, Berlin, Germany

  • Jürgen Braun, MD · Rheumazentrum Ruhrgebiet, Herne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715091 on ClinicalTrials.gov