NCT01111344

Brief Summary

The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in the treatment of external anogenital warts in children and adolescents. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 76. Variables to be assessed will be: time to disappearance of lesions, reduction of the number of lesions and change in the aspect of lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

April 26, 2010

Last Update Submit

May 6, 2012

Conditions

External Anogenital Warts

Keywords

Dietary supplementAnogenital wartsViusidGlizigen

Outcome Measures

Primary Outcomes (1)

  • Time to lesion regression

    Excellent: Lesion regression before 2 weeks of treatment Good: Lesion regression between 2-5 weeks of treatment Poor: Lesion regression between 5-8 weeks of treatment Bad: No lesion regression after 8 weeks of treatment.

    12 weeks

Secondary Outcomes (3)

  • Occurrence of adverse effects within the 12 week treatment period

    12 weeks

  • Reduction in the number of lesions

    12 weeks

  • Lesion aspect

    12 weeks

Study Arms (2)

Glizigen + Viusid

EXPERIMENTAL
Dietary Supplement: Glizigen + Viusid

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Glizigen + ViusidDIETARY_SUPPLEMENT

Glizigen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses). * 1 to 3.9 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_3 daily applications * 4 to 6.9 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_4 daily applications * 7 to 10 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement. Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.

Glizigen + Viusid
PlaceboDIETARY_SUPPLEMENT

Placebo Glizipen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses). * 1 to 3.9 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_3 daily applications * 4 to 6.9 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_4 daily applications * 7 to 10 cm2 \_\_\_\_\_\_\_\_\_\_\_\_\_\_5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement. Placebo Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.

Placebo

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • No previous treatment for anogenital warts
  • Negative serology for HB and HIV.
  • Signed informed consent.

You may not qualify if:

  • Pregnancy
  • Treatment with steroids, immune-suppressors, immune-modulators or local or systemic antiviral drugs.
  • Hypersensitivity to Glizigen or Viusid:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hospital "Dr. Juan Manuel Márquez".

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Viusid

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edelisa Moredo Romo, MD

    Pediatric Hospital "Dr. Juan Manuel Márquez.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 27, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

CU(1)