EUCTR2018-002387-86-DE进行中（未招募）1 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, 4-ARM PILOT STUDY ON THE USE OF PASCORBIN® AS ADD-ON THERAPY IN PATIENTS WITH ACUTE HERPES ZOSTER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
- •1. Male and female patients older than 18 years
- •2. Diagnosis of acute herpes zoster
- •3. Presence of at least one efflorescence
- •4. Peak NRS pain score = 5 within the last 24h
- •5. Based on the appraisal of the investigator: adequate educational as well as intelli-gence level and communicative capacity in order to comply with the requirements of the trial
- •6. Written informed consent of the patient
- •7. Negative urine pregnancy test at the baseline visit (prior to the first intake of study medication) for female patients of childbearing potential.
- •8. Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (oestrogen and progestogen), or some intrauterine devices (IUDs) or sexual abstinence (true absti-nence, only if in line with the preferred and usual lifestyle) or vasectomy of partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least 1 years without sponta-neous menses.
- •9. Patients are suitable for study participation according to their general medical situation
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. History of oxalate-urolithiasis or nephrolithiasis
- •2. Current active zoster episode for more than 10 days
- •3. Known severe renal function impairment consistent with Kidney Disease Improv-ing Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (< 30 ml/min/1.73m2)
- •4. Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
- •5. Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
- •6. Prior vaccination with Zostavax®
- •7. Signs or symptoms or diagnosed complications of herpes zoster such as zoster disseminatus, zoster generalisatus, zoster meningitis, zoster encephalitis, zoster myelitis, zoster pneumonitis, acute retinal necrosis (ARN)
- •8. Contraindication to aciclovir treatment according to the current Summary of Prod-uct Characteristics (SmPC).
- •9. Any disease that may interfere with the assessment of the course of the acute vari-cella zoster virus reactivation e.g.
- •a. dermatological diseases such as psoriasis/eczema in the area of affected dermatomes
- •b. painful local or systemic diseases such as wound infection or inflammation
- •10. Immunodeficiency diseases, including but not limited to Human Immunodeficien-cy Virus (HIV)
- •11. Known active malignancies other than non-melanoma skin cancer (NMSC)
- •12. Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respira-tory obstructive diseases
- •13. Other severe concomitant diseases with severe impairment of the patient’s general condition
- •14. History of additional herpes zoster in the last 3 months prior to baseline
- •15. Any of the following medication, that might interact with the study medication or in-terfere with its effect
- •a. Intravenous or oral virostatics like aciclovir or brivudin longer than 48 hours within the last 4 weeks
- •b. Any supplementary ascorbic acid (vitamin C) within 4 weeks prior to base-line
- •c. Long-term analgesics (including local and transdermal) for non-Herpes pain (e.g. headache, rheumatism)
- •d. Intake of any analgesics longer than 3 days for treatment of the current zos-ter symptoms
- •e. Anticonvulsive drugs (gabapentin, pregabaline) within 4 weeks prior to baseline
- •f. Antiepileptic drugs (carbamazepine) within 4 weeks prior to baseline
- •g. Antidepressant drugs such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) within 4 weeks prior to baseline
- •h. Neuroleptics within 2 days prior to baseline
- •i. Use of topical analgesics e.g., lidocaine or capsaicin patches on the site of the current herpes zoster efflorescence within 2 days prior to baseline
- •16. Current therapy with immunosuppressive drugs, including but not limited to:
- •a. Any systemic chemotherapeutics/cytostatic drugs
- •b. Corticosteroids (> 5 mg/d prednisolone or equivalent)
- •c. Methotrexate, ciclosporin, azathioprine
- •17. Other drugs and interventions that may cause interactions with Pascorbin®, in-cluding
- •a. Fluphenazine
- •b. Cumarine derivates
- •c. Radiation therapy
- •18. Nephrotoxic drugs, that may, according to the investigator’s discretion, impair renal function
- •19. Any other non-drug treatment of the acute herpes zoster
- •20. Known hypersensitivity to the pharmacologic active constituents or any other in-gredient of the study medication
- •21. Participation in another clinical trial within the last 30 days prior to inclusion, sim-ultaneous participation in another clinical trial or previous participation in this trial.
- •22. Mental or physical d
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