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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689143
First Posted: June 3, 2008
Last Update Posted: October 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uppsala University
Information provided by:
Innoventus Project AB
May 29, 2008
June 3, 2008
October 29, 2008
August 2008
October 2008   (Final data collection date for primary outcome measure)
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days.
Complete list of historical versions of study NCT00689143 on ClinicalTrials.gov Archive Site
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days.
Not Provided
Not Provided
 
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Periodontitis
Drug: sargramostim
Other Names:
  • GM-CSF
  • Leukine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00689143
IPPIS-0604
No
Not Provided
Not Provided
Innoventus Project AB
Innoventus Project AB
Uppsala University
Principal Investigator: Jan Hirsch, Prof. Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
Innoventus Project AB
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP