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van CCT (UK)


Reduction of adverse effects by systemic antihistamines during therapy with fumarates in severe chronic plaque psoriasis.


- candidate number2188
- NTR NumberNTR744
- ISRCTNISRCTN12758639
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR1-aug-2006
- Secondary IDsN/A 
- Public TitleReduction of adverse effects by systemic antihistamines during therapy with fumarates in severe chronic plaque psoriasis.
- Scientific TitleReduction of adverse effects by systemic antihistamines during therapy with fumarates in severe chronic plaque psoriasis: a randomized, placebo-controlled clinical trial.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPsoriasis
- Inclusion criteria1. Patients with known severe psoriasis of the chronic plaque type
2. PASI > 10
3. Age > 18 years
4. Psoriasis therapies cannot be administered starting from 28 days before baseline visit until discontinuation of the study medications at the end of the study.
5. All forms of ultraviolet light therapy are prohibited during the study through week 12, such as PUVA and UVB (including narrow band UVB and excimer laser). Puva is prohibited starting from 28 days before the baseline and UVB is prohibited starting from 14 days before baseline.
6. All forms of topical psoriasis therapies cannot be administered from 14 days before baseline until discontinuation of the study medications through week 12.
7. Investigational or biological drugs are not permitted from 28 days prior to screening visit until discontinuation of the study medication at the end of study.
- Exclusion criteria1. Pregnancy and breast feeding
2. Patients with Prostate hyperplasia, Glaucoma, Stomach ulcer
3. Patients with liver diseases
4. Patients with kidney diseases
5. Patients with blood test deviations
6. Patients with gastro-intestinal diseases
7. Patients with a history of malignancies
8. Presence of clinically significant renal and hepatic laboratory values ( i.e.,male patients with serum creatinine 133 umol/L; female patients with serum creatinine 124 umol/L; ALT, AST, total bilirubin, GGT, or Alkaline Phosphatase > 2.5 times the upper limit of the reference range).
9. Serum lipase impairments (total cholesterol > 6.5 mmol/l, LDL-cholesterol > 2mmol/l, triglyceride > 3 mmol/l).
10. Hemoglobin parameters must satisfy the following criteria:
10.1 hemoglobin < 7.5 mmol/l
10.2 leukocytes > 3.50*10E9/l and < 10*10E9/l
10.3 lymphocytes > 15% and < 50% of the total white cell count.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-jan-2008
- Target number of participants40
- InterventionsRandomization in two groups. One patient group will receive fumarate therapy combined with levocetirizine. The other patient group will receive fumarate therapy combined with a placebo instead of levocetirizine.
- Primary outcomePASI-score
- Secondary outcomeskin-biopsies
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Fallah-Arani
- CONTACT for SCIENTIFIC QUERIES S. Fallah-Arani
- Sponsor/Initiator Erasmus Medical Center, Department of Dermatology and Venereology
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD1-aug-2006 - 4-dec-2006


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