A double-blind, placebo-controlled, 4-arm pilot study on the use of Pascorbin® as add-on Therapie in patients with acute Herpes zoster
- Conditions
- Acute herpes zoster infectionMedDRA version: 20.0Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-002387-86-DE
- Lead Sponsor
- Pascoe pharmazeutische Präparate GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 76
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Area under the curve (AUC) of mean neuropathic pain measured by numeric rating scale (NRS) from baseline to V5;Secondary Objective: • Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5<br>• AUC of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5<br>• Proportion of patient who developed a post-herpetic neuralgia at V7<br>;Primary end point(s): Comparison of efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo. ;Timepoint(s) of evaluation of this end point: Visit 5
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5<br>• AUC of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5<br>• Proportion of patient who developed a post-herpetic neuralgia at V7<br>;Timepoint(s) of evaluation of this end point: Visit 5, and visit 7, respectively