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| [ Print-friendly version ] |
| Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone |
| ISRCTN | ISRCTN48188950 |
| ClinicalTrials.gov identifier | |
| Public title | Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NTR169 |
| Study hypothesis | Dexamethasone pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis. |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Myositis, dermatomyositis, polymyositis |
| Participants - inclusion criteria |
1. Polymyositis
2. Dermatomyositis 3. Myositis with rheumatological disorders 4. Myositis with cancer 5. Unspecified myositis |
| Participants - exclusion criteria |
1. Myositis in family
2. Greater than 3/1000 rimmed vacuoles 3. Quick (less than 2 weeks) rise and spontaneous normalisation (less than 2 months) of serum creatine kinase (CK) level 4. Aged less than 18 years 5. Contra-indication for one of the two treatments 6. Desire to get pregnant or active pregnancy 7. No informed consent 8. Greater than 20 mg prednisone/day |
| Anticipated start date | 01/07/2001 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 80 |
| Interventions |
1. Dexamethasone pulse therapy. 40 mg/dag every first four days of the month, for 6 months. Placebo on the other days of the months.
2. Prednisolone 1 - 1.5 mg/kg/day for 4 weeks, after this slow reduction in dose Both groups treatment against osteoporosis with calci-chew and Fosamax. |
| Primary outcome measure(s) |
1. Combined scale: Rankin, muscle strength, Visual Analogue Scale (VAS) pain, time until remission, no relapse, no cushing, no osteoporosis
2. Percentage patients in remission, time to remission, no relapse 3. General assessment of condition of patients |
| Secondary outcome measure(s) |
1. Weight
2. Blood pressure 3. VAS arthralgia, Raynaud 4. Skin changes 5. CK 6. Myometry 7. VAS dysphagia 8. VAS agitation 9. Quality of life 10. Medication and dose 11. Other side effects 12. Neuromusclular symptom score |
| Sources of funding | Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr J. van de Vlekkert |
| Address |
Academical Medical Centre
Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 566 9111 |
| j.vandevlekkert@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address | Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Sponsor website: | http://www.amc.uva.nl/ |
| Date applied | 20/12/2005 |
| Last edited | 16/09/2008 |
| Date ISRCTN assigned | 20/12/2005 |
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