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

This study has been completed.
Sponsor:
Collaborator:
Uppsala University
Information provided by:
Innoventus Project AB
ClinicalTrials.gov Identifier:
NCT00689143
First received: May 29, 2008
Last updated: October 28, 2008
Last verified: October 2008

May 29, 2008
October 28, 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 [ Designated as safety issue: Yes ]
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days. [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: No ]
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days. [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00689143
IPPIS-0604
No
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