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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00900783
Other study ID # INH-FV1-005
Secondary ID INH-FV1-005-PKIN
Status Completed
Phase Phase 2
First received May 12, 2009
Last updated September 23, 2015
Start date May 2009
Est. completion date December 2010

Study information

Verified date September 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include:

- Compare the safety of FV-100 to valacyclovir

- Compare the effect of FV-100, as compared to valacyclovir, on shingles pain

- Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Men and women = 50 years of age

- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash

- Patients with zoster-related pain (ZBPI worst pain score > 0)

- Patients able to be enrolled into the study = 72 hours from appearance of rash (i.e., lesions or vesicles)

- Patients providing written informed consent

- Patients who are able to complete all study visits per protocol

- Men and premenopausal women must agree to practice a barrier method of birth control plus the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted)

Exclusion Criteria:

- Women who are pregnant or lactating

- Patients with multidermatomal or disseminated HZ (i.e., > 20 vesicles beyond the dermatomes adjacent to the primarily involved dermatome)

- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve

- Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)

- Patients taking narcotic analgesic routinely for a chronic pain condition

- Patients taking tricyclic antidepressants

- Patients who have received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ

- Patients who are immunosuppressed from:

- disease (e.g., malignancy [present or remission < 5 years], HIV)

- corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent < 800 mcg/day), or

- other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)

- Patients with gastrointestinal dysfunction that could interfere with drug absorption

- 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

- 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

- Patients with history of allergy to valacyclovir hydrochloride

- Patients unlikely to adhere to protocol follow-up

- 14. Subjects taking strong CYP3A4-inhibiting protease inhibitors (specifically including atazanavir, indinavir, nelfinavir, saquinavir, and ritonavir), strong CYP3A4 inhibitors (specifically including clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin) and all strong CYP3A4 inducers (specifically including rifampin, efavirenz, etravirine, phenobarbital, phenytoin, and carbamazepine)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
valacyclovir
1 gram, three times a day for seven days
FV-100
400 mg, once daily, for seven days
FV-100
200 mg, once daily, for seven days
Valacyclovir placebo
three times a day, for seven days
FV-100 placebo
once daily, for seven days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Outcome

Type Measure Description Time frame Safety issue
Primary Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI) 30 days No
Secondary Herpes zoster associated pain 90 days No
Secondary Herpes zoster lesion healing Until healed No
Secondary Routine clinical labs 30 days Yes
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