Health Condition 1: null- Acute herpes zoster in immunocompetent adult Health Condition 2: B108- Other human herpesvirus infection
Conditions
Interventions
Intervention1: Brivudin Tablets: once daily for 7 days
Control Intervention1: Famciclovir Tablets: Three times daily for 7 days
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a clinical diagnosis of herpes zoster as evidenced by a unilateral dermatomal rash 2. Patients with zoster-related pain. 3. Patients able to be enrolled into the study equal and less than 72 hours from appearance of rash (i.e., lesions or vesicles) 4. Patients providing written informed consent 5. Patients who are able to complete all study visits per protocol.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating 2. Patients with multidermatomal or disseminated herpes zoster 3. Patients with herpes zoster ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve 4. Patients with history of impaired renal function. 5. Patients taking narcotic analgesic routinely for a chronic pain condition 6. Patients taking tricyclic antidepressants 7. Patients who have received systemic antivirals drugs within the past 30 days, or a topical antiviral to treat their current herpes zoster 8. Patients who are immunosuppressed from: a.disease (e.g., malignancy, HIV) b. corticosteroid c. other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation) 9. Patients with gastrointestinal dysfunction that could interfere with drug absorption 10. Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study. 11. Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements 12. Patients with history of allergy to famciclovir 13. Patients unlikely to adhere to protocol follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extreme sensitivity or pain in a broad band on one side of the body, itching, tingling, burning, constant aching, shootingTimepoint: Day 0, 3, 5 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain, Chills, Difficulty moving some of the muscles in the face, Drooping eyelid (ptosis), Fever, General ill-feeling, Genital lesions, Headache, Hearing loss, Joint pain, Loss of eye motion (ophthalmoplegia), Swollen glands (lymph nodes), Taste problems, Vision problemsTimepoint: Day 0, 3, 5 and 7;Safety and TolerabilityTimepoint: Day 0, 3, 5 and 7 | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed