- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00689143
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
October 28, 2008 updated by: Innoventus Project AB
A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days
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.
Study Overview
Detailed Description
It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, SE-751 85
- Dept of Oral & Maxillofacial Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals (male or female) referred to Dept of Oral & Maxillofacial surgery to have a lower wisdom tooth surgically extracted
- ≥ 20 and ≤ 40 years of age
- Analysis results of blood status within normal reference ranges
- Ability to attend the scheduled visits for evaluation procedures
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- Signed informed consent
Exclusion Criteria:
- Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
- An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
- Current use of anti-coagulant therapy or within 10 days from baseline
- Current use of immunomodulating medication
- Current use of corticosteroids (Amendment 1: topical use permitted).
- Current use of lithium.
- Use of tobacco products or nicotine replacement therapy
- Alcohol or drug abuse
- HIV or hepatitis infection
- Pregnancy or lactation
- Participation in another clinical study on medicinal products at the time of inclusion
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
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Secondary Outcome Measures
Outcome Measure |
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To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan Hirsch, Prof., Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
May 29, 2008
First Submitted That Met QC Criteria
June 2, 2008
First Posted (Estimate)
June 3, 2008
Study Record Updates
Last Update Posted (Estimate)
October 29, 2008
Last Update Submitted That Met QC Criteria
October 28, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPPIS-0604
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
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Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
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Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
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Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
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Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
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Aga Khan UniversityCompletedChronic Apical PeriodontitisPakistan
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