Long-term Safety of Minocycline in Patients With Gum Disease

Periodontitis Clinical Trial

Official title:

Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668746
• Other study ID #: OP-P-5756-1
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: December 6, 2011
• Start date: December 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: OraPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.

Description:

The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• generally healthy

• over 25 years of age

• moderate-to-severe chronic periodontitis

• documented informed consent

• willing to comply with contraceptive requirements

• free from any significant oral soft tissue pathology

Exclusion Criteria:

• willing to adhere to prohibitions and restrictions of the study

• oral health inappropriate for study inclusion

• females self-reporting pregnancy or lactation, or having a positive urine pregnancy result

• reporting any of the following conditions:

• allergy to a tetracycline-class drug

• systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures

• active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis

• diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement

• participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment

• employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator

• anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Minocycline HCl microspheres
At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD = 5mm.

Locations

Country	Name	City	State
United States	Forsyth Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
OraPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture	Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.	from Baseline to Day 30 and Day 180	No
Secondary	Micocycline-Resistance From Plaque Samples	Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples	Baseline, Day 30 and Day 180	No
Secondary	Micocycline-Resistance From Saliva Sample	Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects	Baseline, Day 30 and Day 180	No