Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (control group) | Placebo Comparator | 300 ml NaCl infusion |
|
| Group 2 (750 mg Vitamin C) | Experimental | 295 ml NaCl + 5 ml (750 mg) Vitamin C |
|
| Group 3 (7.5 g Vitamin C) | Experimental | 250 ml NaCl + 1 x 50 ml (7.5 g) Vitamin C |
|
| Group 4 (15 g Vitamin C) | Experimental | 200 ml NaCl + 2 x 50 ml (2 x 7.5 g) Vitamin C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean neuropathic pain | Area under the curve (AUC) of mean neuropathic pain measured by numeric rating scale (NRS) from baseline to V5 | from Baseline to V5 (day 11-13 after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of standard doses of permitted concomitant analgesic medication | Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5 Step 1 (non-opioids: Paracetamol 500 mg, Ibuprofen 400 mg) | from Baseline to V5 (day 11-13 after baseline) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of oxalate-urolithiasis or nephrolithiasis
Current active zoster episode for more than 10 days
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)
Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
Prior vaccination with Zostavax®
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)
Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).
Any disease that may interfere with the assessment of the course of the acute varicella zoster virus reactivation e.g.
Immunodeficiency diseases, including but not limited to Human Immunodeficiency Virus (HIV)
Known active malignancies other than non-melanoma skin cancer (NMSC)
Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respiratory obstructive diseases
Other severe concomitant diseases with severe impairment of the patient's general condition
History of additional herpes zoster in the last 3 months prior to baseline
Any of the following medication, that might interact with the study medication or interfere with its effect
Current therapy with immunosuppressive drugs, including but not limited to:
Other drugs and interventions that may cause interactions with Vitamin C, including
Nephrotoxic drugs, that may, according to the investigator's discretion, impair renal function
Any other non-drug treatment of the acute herpes zoster
Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication
Participation in another clinical trial within the last 30 days prior to inclusion, simultaneous participation in another clinical trial or previous participation in this trial.
Mental or physical disability or imprisonment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Holger Michels | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Andraes Pinter, Dr. | Universitätsklinik Frankfurt am Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| dermatologisches zentrum Bonn | Bonn | Hesse | 53111 | Germany | ||
| Universitätsklinikum Frankfurt am Main |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AUC of equianalgesic doses of permitted concomitant analgesic medication |
Area under the curve of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5 Step 2 (weak opioids: Metamizole 500 mg, Tramadol 50 mg, Tilidine/Naloxone 50 mg/4 mg) |
| from Baseline to V5 (day 11-13 after baseline) |
| Presence of a Post-herpetic neuralgia | Proportion of patient who developed a post-herpetic neuralgia at V7 | at V7 (day 90 (+/- 2 days)) |
| Frankfurt am Main |
| Hesse |
| 60590 |
| Germany |
| Hautklinik der Universitätsmedizin Mainz KöR | Mainz | Hesse | 55101 | Germany |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |