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Study of rBet v1 Tablets

NCT00901914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 483

Last updated 2013-06-27

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Conditions

  • Birch Pollen-related Rhinoconjunctivitis
  • Rhinitis, Allergic, Seasonal

Interventions

BIOLOGICAL

Placebo

One sublingual tablet of matching placebo daily during approximately 5.5 months

BIOLOGICAL

rBet v 1

One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months

BIOLOGICAL

rBet v 1

One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months

BIOLOGICAL

rBet v 1

One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Aptuit

    collaborator INDUSTRY

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Sabina Rak, MD. PR · Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Lithuania
  • Poland
  • Russia
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT00901914 on ClinicalTrials.gov