Acute herpes zoster infection MedDRA version: 20.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Pascorbin®
Product Name: Pascorbin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ASCORBIC ACID
CAS Number: 50-81-7
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
Pascoe pharmazeutische Präparate GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • AUC of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5 • Proportion of patient who developed a post-herpetic neuralgia at V7 ;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
| Measure | Time frame |
|---|---|
| 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 • AUC of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5 • Proportion of patient who developed a post-herpetic neuralgia at V7 ;Timepoint(s) of evaluation of this end point: Visit 5, and visit 7, respectively | — |
Countries
Germany
Contacts
Public ContactHolger Michels
Pascoe pharmazeutische Präparate GmbH
Outcome results
None listed