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Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy (PVBP)

Primary Purpose

Bell´s Palsy

Status
Completed
Phase
Not Applicable
Locations
Uruguay
Study Type
Interventional
Intervention
prednisone- valacyclovir
prednisone-placebo
Sponsored by
Universidad de la Republica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell´s Palsy focused on measuring Bell´s palsy, prednisone, valacyclovir

Eligibility Criteria

14 Years - 82 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Bell´s palsy evaluated within the first 72 hours.

Exclusion Criteria:

  • Peptic ulcer
  • Tuberculosis
  • Moderate or severe diabetes
  • Moderate or severe hypertension
  • Glaucoma
  • Manifest cardiac disease
  • Psychosis
  • Renal or hepatic dysfunction, and
  • Pregnancy.

Sites / Locations

  • Hospital de clinicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The following parameters were used to evaluate the final result: grade of recovery, and sequelae.Facial nerve function was assessed using the facial grading system (FGS) Normal recovery was defined as the return of facial function to FGS 90 or more.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2007
Last Updated
November 19, 2007
Sponsor
Universidad de la Republica
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1. Study Identification

Unique Protocol Identification Number
NCT00561106
Brief Title
Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy
Acronym
PVBP
Official Title
Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad de la Republica

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.
Detailed Description
Between December 2002 and December 2003, a total of 52 subjects with BP were evaluated, 42 fulfilled the inclusion criteria and entered the study, 1 patient was lost to follow-up after the first visit, leaving a total of 41 patients with complete clinical follow-up. To be included in the study, patients had to be evaluated within the first 72 hours and could have no contraindications to steroid or valacyclovir therapy. Patients were randomly assigned to either the prednisone-valacyclovir (group 1) or the prednisone-placebo group (group 2) Among the 41 patients completing the study, 19 pertenecian al group 1 and 21 group 2 Both groups received prednisone, a dose of 1 mg/kg body weight was given daily for 7 days (one single dose after breakfast). The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days. All subjects were instructed about eye protection and lubrication were followed at regular intervals until recovery or for a minimum period of 3 months. Follow-up included examination at 1, 2, 4, 8 and 12 weeks after the first visit. Patients with incomplete recovery at 3 months were controlled until complete recovery or stabilization of the paralysis. All subjects were evaluated for laboratories parameters. Routine blood count, blood sugar, and liver function tests were performed at first visit. There were no severe side effects attributable to the valacyclovir-prednisone treatment in this study. Informed consent was obtained from all patients. Facial nerve function was assessed using the facial grading system (FGS) The scale used provides a quantitative score with three components; resting symmetry, symmetry of voluntary movement and synkinesis and a composite score was obtained. Student's t-test was employed for quantitative….variables. Comparison of treatment results between both groups was performed by….means of an analysis of variance (ANOVA) test of two ways (therapy and time). All statistical tests were considered received the same level of significance (P = 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell´s Palsy
Keywords
Bell´s palsy, prednisone, valacyclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
prednisone- valacyclovir
Intervention Description
prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.
Intervention Type
Drug
Intervention Name(s)
prednisone-placebo
Intervention Description
prednisone, a dose of 1 mg/kg body weight was given daily for 7 days
Primary Outcome Measure Information:
Title
The following parameters were used to evaluate the final result: grade of recovery, and sequelae.Facial nerve function was assessed using the facial grading system (FGS) Normal recovery was defined as the return of facial function to FGS 90 or more.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Bell´s palsy evaluated within the first 72 hours. Exclusion Criteria: Peptic ulcer Tuberculosis Moderate or severe diabetes Moderate or severe hypertension Glaucoma Manifest cardiac disease Psychosis Renal or hepatic dysfunction, and Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Vazquez, Dr.
Organizational Affiliation
Hospital de Clinicas Facultad de Medicina Universidad de la Republica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de clinicas
City
Montevideo
ZIP/Postal Code
11600
Country
Uruguay

12. IPD Sharing Statement

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Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy

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