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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00689143 |
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Date of registration:
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29/05/2008 |
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Primary sponsor: |
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Public title:
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A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
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Scientific title:
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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 |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00689143 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Jan Hirsch, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontitis
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Intervention(s)
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Drug: sargramostim
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Primary Outcome(s)
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To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
[Time Frame: Yes]
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Secondary Outcome(s)
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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
[Time Frame: No]
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Secondary ID(s)
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IPPIS-0604
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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