Long-term Safety of Minocycline in Patients With Gum Disease - Full Text View

Sponsor:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00668746

Purpose

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.

Condition	Intervention	Phase
Periodontitis	Drug: Minocycline HCl microspheres	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

Resource links provided by NLM:

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:

Change in the proportion (percent) of minocycline-resistant bacteria (as measured by bacterial culture) for whole, unstimulated saliva and subgingival plaque [ Time Frame: from Baseline to Day 730 +/- 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in the proportion (percent) of minocycline-resistant bacteria for saliva and subgingival plaque and total number of minocycline-resistant bacteria [ Time Frame: from Baseline to all other time points (i.e., Days 30 to 635) ] [ Designated as safety issue: No ]
Identification of minocycline-resistant species within a panel of 40 representative periodontal species [ Time Frame: from baseline to all other time points through Day 730 ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	December 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Minocycline HCl microspheres: Experimental Minocycline HCl microspheres	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.
No drug intervention: No Intervention No drug intervention

Detailed 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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668746

Locations

United States, Massachusetts
Forsyth Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Michael Lynch, DMD, PhD

OraPharma

More Information

No publications provided

Responsible Party:	JJCPPW ( Joyce Hauze/Senior Project Manager )
Study ID Numbers:	OP-P-5756-1
Study First Received:	April 24, 2008
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00668746 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer & Personal Products Worldwide:

chronic periodontitis, antibiotic resistance

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Periodontal Diseases

Periodontitis
Therapeutic Uses
Stomatognathic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010