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Scandinavian Bell's Palsy Study

NCT00510263 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 839

Last updated 2008-06-04

No results posted yet for this study

Summary

The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied.

Conditions

  • Bell's Palsy

Interventions

DRUG

Prednisolone + placebo

Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.

DRUG

Valaciclovir + placebo

Valaciclovir 500 mg 2 tablets 3 times daily for 7 days. Placebo tablets 12 per day for 5 days, tapering 2 tablets per day until day 10.

DRUG

Prednisolone + valaciclovir

Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Valaciclovir 500 mg 2 tablets 3 times daily for 7 days.

DRUG

Placebo + placebo

Placebo 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Mats Engstrom, M.D., Ph.D. · Uppsala University, Sweden

  • Lars Jonsson, M.D., Ph.D. · Uppsala University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2007-09-30
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510263 on ClinicalTrials.gov