Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster (NCT05561257) | Clinical Trial Compass
TerminatedPhase 2
Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster
Stopped: the necessary recruitment was no longer ensured and fundamental changes in the medical care of herpes zoster, which prevented the original research objectives and the feasibility of the study in the planned scope from being achieved
Germany12 participantsStarted 2020-07-20
Plain-language summary
To compare the efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo and the reduction of herpes zoster-associated clinical symptoms as an add-on therapy for patients suffering from acute herpes zoster in primary care
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Male and female patients older than 18 years
âś“. Diagnosis of acute herpes zoster
âś“. Presence of at least one efflorescence
✓. Peak NRS pain score ≥ 5 within the last 24h
âś“. Based on the appraisal of the investigator: adequate educational as well as intelligence level and communicative capacity in order to comply with the requirements of the trial
âś“. Written informed consent of the patient
âś“. Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of childbearing potential.
âś“. 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 abstinence, 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 year without spontaneous menses.
Exclusion criteria
âś•. History of oxalate-urolithiasis or nephrolithiasis
âś•. Current active zoster episode for more than 10 days
What they're measuring
1
Mean neuropathic pain
Timeframe: from Baseline to V5 (day 11-13 after baseline)
. Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (\< 30 ml/min/1.73m2)
âś•. Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
âś•. Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
✕. Prior vaccination with Zostavax®
âś•. 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)
âś•. Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).