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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689143
• Other study ID #: IPPIS-0604
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2008
• Last updated: October 28, 2008
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Innoventus Project AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• sargramostim

Locations

Country	Name	City	State
Sweden	Dept of Oral & Maxillofacial Surgery	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Innoventus Project AB	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days			Yes
Secondary	To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days			No