EUCTR2012-005483-10-IE进行中（未招募）1 期
Dipeptidyl peptidase-4 Inhibition and Narrow-band Ultraviolet-B light in Psoriasis (DINUP): A Randomised Clinical Trial.
niversity College Dublin0 个研究点开始时间: 2013年2月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •People who satisfy all of the following may be included in the study:
- •1. Have a diagnosis of generalized chronic plaque and/or guttate psoriasis;
- •2. Are male and female patients aged between 18 and 75 years inclusive;
- •3. Have a psoriasis area and severity index (PASI) greater than 7 despite use of topical therapies;
- •4. Are due to undergo NB-UVB light therapy;
- •5. Have not required systemic psoriasis therapy during the past eight weeks;
- •6. Are unlikely to require systemic therapy for the duration of clinical trial involvement;
- •7. Have a negative pregnancy test at screening (women of child bearing potential only); and
- •8. Are willing to sign voluntarily a statement of informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •People with any of the following conditions will be excluded from the study:
- •1. Photosensitive disorders (lupus erythematosis etc);
- •2. Diabetes mellitus;
- •3. Use of medications that can cause photosensitivity;
- •4. Conditions that could be made worse by phototherapy (cataract, epilepsy, etc);
- •5. Allergy or hypersensitivity to Januvia®;
- •6. Severe kidney disease as defined by a previous diagnosis of chronic kidney disease in the presence of an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 m2;
- •7. Recent (within 8 weeks) receipt of NB-UVB light;
- •8. Current or recent (within 8 weeks) use of systemic therapy for psoriasis;
- •9. Severe heart disease as defined by a previous diagnosis of heart disease and a left ventricular ejection fraction which is known to be less than 35% (as measured by echocardiogramme or cardiac catheterisation study);
- •10. Severe lung disease as defined by a previous diagnosis of chronic lung disease and a forced expiratory volume in 1 second (FEV1) or a forced vital capacity (FVC) that is known to be less than 50% that which would be estimated for a person of that age and gender;
- •11. Severe liver disease as defined by a previous diagnosis of chronic liver disease in the presence of an alanine transferase concentration greater than 150IU/L (greater than three times the upper limit of the normal reference range);
- •12. Any other contraindications to Januvia® as stated in its SPC;
- •13. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception during participation in the study – abstinence will be permitted only if it is in keeping with a person’s lifestyle;
- •14. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial;
- •15. A current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness;
- •16. Previous randomisation into this study;
- •17. Concurrent participation in another clinical trial; and
- •18. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).
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