|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Charite University, Berlin, Germany |
|---|---|
| Information provided by: | Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00715091 |
Purpose
This is a randomised, controlled, multi-centre clinical trial on 360 AS patients. Experimental intervention: continuous (daily) treatment of 180 patients with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice dailyControl intervention: treatment on-demand (as needed) of 180 patients 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: diclophenac |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial |
| Estimated Enrollment: | 360 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
continuous (daily) treatment of 180 patients with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice daily
|
Drug: diclophenac
continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily
|
|
2: Active Comparator
treatment on-demand (as needed) of 180 patients with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment strategy of the control intervention (on-demand) reflects current clinical practice in AS.
|
Drug: diclophenac
treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily
|
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 by chronic pain, fatigue and morning stiffness, later on by ankylosis and loss of function. Nonsteroidal anti-inflammatory drugs (NSAID) and tumor necrosis factor (TNF) alpha blocking agents are the only drugs with proven efficacy for signs and symptoms. It is not clear, however, whether these drugs are also capable of retarding or stopping structural damage, i.e. prevention of bony ankylosis. Earlier investigations indicated that NSAIDs have, in addition to their anti-inflammatory, also an anti-osteoproliferative effect. In this study we will investigate whether treatment with 150 mg diclofenac, a non-selective NSAID, on a daily basis (continuous treatment) over 2 years is capable to slow down the development of bony ankylosis as compared to treatment with 75-150mg diclofenac as needed according to clinical symptoms (on-demand treatment). In this national multi-centre randomized trial 360 patients with symptomatic AS and indication for NSAID therapy will be enrolled in about 40 centres. The primary outcome parameter is the proportion of patients with radiographic progression in the spine after 2 years in each treatment arm. If continuous NSAID treatment results in less radiographic progression as compared to on-demand treatment, a true disease modifying effect of NSAID has to be assumed which will most likely change the place of NSAID treatment in AS.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martin Rudwaleit, MD | +49-30-8445 ext 4547 | martin.rudwaleit@charite.de |
| Contact: In-Ho Song, MD | +49-30-8445 ext 4795 | in-ho.song@charite.de |
| Germany | |
| Brandt | |
| Berlin, Germany, 12163 | |
| Praxis Bohl-Bühler | |
| Potsdam, Germany, 14469 | |
| Praxis Mielke | |
| Berlin, Germany, 12627 | |
| St. Josefs-Krankenhaus, Rheumatologie | |
| Herne, Germany, 44652 | |
| Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus | |
| Herne, Germany, 44652 | |
| Praxis Dr. Kühne | |
| Haldensleben, Germany, 39340 | |
| Praxis Zinke | |
| Berlin, Germany, 13055 | |
| Praxis Dr. Pick | |
| Grafschaft bei Bad Neuenahr-Ahrweiler, Germany, 53501 | |
| Praxis Dr. Kapelle | |
| Hoyerswerda, Germany, 02977 | |
| Praxis Dr. Gräßler | |
| Pirna, Germany, 01796 | |
| Gemeinschaftspraxis Dr. Schwenke | |
| Dresden, Germany, 01109 | |
| Gemeinschaftspraxis Dr. Kolitsch | |
| Katzhütte, Germany, 98746 | |
| Germany, Baden-Württemberg | |
| Medizinische Universitätsklinik Innere Medizin | |
| Tübingen, Baden-Württemberg, Germany, 1072076 | |
| Praxis Dr. Jacki | |
| Tübingen, Baden-Württemberg, Germany, 72072 | |
| Germany, Bayern | |
| Praxis Dr. Manger | |
| Bamberg, Bayern, Germany, 96047 | |
| Praxis Dr. Ochs | |
| Bayreuth, Bayern, Germany, 95445 | |
| Praxis Dr. Kellner | |
| München, Bayern, Germany, 80639 | |
| Praxiszentrum St. Bonifazius | |
| München, Bayern, Germany, 81541 | |
| Gemeinschaftspraxis Dr. Göttl | |
| Passau, Bayern, Germany, 94032 | |
| Germany, Niedersachsen | |
| Gemeinschaftspraxis Dr. von Hinüber | |
| Hildesheim, Niedersachsen, Germany, 31134 | |
| Praxis Dr. Dockhorn | |
| Weener, Niedersachsen, Germany, 26828 | |
| Gemeinschaftspraxis Dr. Gauler | |
| Osnabrück, Niedersachsen, Germany, 49076 | |
| Praxis Dr. Rockwitz | |
| Goslar, Niedersachsen, Germany, 38640 | |
| Fachklinik Bad Bentheim | |
| Bad Bentheim, Niedersachsen, Germany, 48455 | |
| Germany, Nordrhein-Westfalen | |
| Praxis Dr. Kramer | |
| Remscheid, Nordrhein-Westfalen, Germany, 42897 | |
| Evangelisches Krankenhaus | |
| Ratingen, Nordrhein-Westfalen, Germany, 40882 | |
| Rheumatologische Schwerpunktpraxis | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40217 | |
| Praxis Dr. Schoo | |
| Rheine, Nordrhein-Westfalen, Germany, 48431 | |
| St. Josefs-Stift | |
| Sendenhorst, Nordrhein-Westfalen, Germany, 48324 | |
| Universitätsklinikum DüsseldorfKlink für Endokrinologie, Diabetologie und Rheumatologie | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40001 | |
| Germany, Sachsen-Anhalt | |
| Rheumatologische Praxis Dr. Spieler | |
| Zerbst, Sachsen-Anhalt, Germany, 39261 | |
| Principal Investigator: | Martin Rudwaleit, MD | Charité University, Berlin, Germany |
| Principal Investigator: | Joachim Sieper, MD | Charité University, Berlin, Germany |
| Principal Investigator: | Jürgen Braun, MD | Rheumazentrum Ruhrgebiet, Herne, Germany |
More Information
| Responsible Party: | Rheumatology, Med. Clinic I, Charite University, Berlin, Germany ( PD Dr. med Martin Rudwaleit ) |
| Study ID Numbers: | ENRADAS-01, EUDA-CT: 2007-007637-39 |
| Study First Received: | July 14, 2008 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00715091 History of Changes |
| Health Authority: | Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices |
|
NSAIDS ankylosing spondylitis SpA Spondyloarthritis radiographic changes |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Bone Diseases Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics Spondylarthritis Spondylitis |
Ankylosis Spondylarthropathies Spinal Diseases Joint Diseases Cyclooxygenase Inhibitors Diclofenac Enzyme Inhibitors Pharmacologic Actions Bone Diseases, Infectious Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |