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Clinical Trials/JPRN-jRCT2080224870
JPRN-jRCT2080224870CompletedPhase 3

Phase III, Placebo-controlled, Randomized, Double-blind, Multicenter, Parallel-group comparative study to Evaluate the Efficacy and Safety of Patient Initiated Therapy of ASP2151 in Patients with Recurrent Herpes Labialis

Maruho Co., Ltd.0 sites1,804 target enrollmentStarted: September 13, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,804
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

In this study, a single dose of ASP2151 1200 mg significantly shortened the time to all lesion healing of recurrent herpes labialis over placebo. Amenamevir was well tolerated and showed no clinically major safety concerns.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to <= 79age old (—)
Sex
All

Inclusion Criteria

  • •Recurrent Herpes Labialis patients

Exclusion Criteria

  • •(1)Patients diagnosed with immunodeficiency or
  • •immunocompromised function (such as patients with congenital immunodeficiency, AIDS patients, patients with HIV infection)
  • •(2)Patients with any disorders that should not be enrolled in the sutdy such as;
  • •-severe cardiac disorders
  • •-severe hepatic disorders
  • •-severe pulmonary disorders
  • •-severe blood disorders
  • •(3)Pregnant women, women who may be pregnant, lactating women or women who wish to become pregnant or women who are unwilling to use a suitable method of contraception as directed by the principal investigator or sub-investigator.

Investigators

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