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A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva

NCT00689143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2008-10-29

No results posted yet for this study

Summary

This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.

Conditions

  • Periodontitis

Interventions

DRUG

sargramostim

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Innoventus Project AB

    lead INDUSTRY

Principal Investigators

  • Jan Hirsch, Prof. · Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Sweden

Study Locations

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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 NCT00689143 on ClinicalTrials.gov