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Long-term Safety of Minocycline in Patients With Gum Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT00668746
First received: April 24, 2008
Last updated: December 6, 2011
Last verified: December 2011
History of Changes

April 24, 2008
December 6, 2011
December 2007
February 2009   (final data collection date for primary outcome measure)
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture [ Time Frame: from Baseline to Day 30 and Day 180 ] [ Designated as safety issue: No ]
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
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: Yes ]
Complete list of historical versions of study NCT00668746 on ClinicalTrials.gov Archive Site
  • Micocycline-Resistance From Plaque Samples [ Time Frame: Baseline, Day 30 and Day 180 ] [ Designated as safety issue: No ]
    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
  • Micocycline-Resistance From Saliva Sample [ Time Frame: Baseline, Day 30 and Day 180 ] [ Designated as safety issue: No ]
    Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
  • 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: Yes ]
  • 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: Yes ]
  • Safety assessments will consist of monitoring and recording all nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to study drug [ Time Frame: throughout duration of the study + 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-term Safety of Minocycline in Patients With Gum Disease
Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Periodontitis
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.
Other Name: minocycline
  • Experimental: Minocycline HCl microspheres
    Minocycline HCl microspheres
    Intervention: Drug: Minocycline HCl microspheres
  • No Intervention: No drug intervention
    No drug intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668746
OP-P-5756-1
No
OraPharma
OraPharma
Not Provided
Study Director: Michael Lynch, DMD, PhD OraPharma
OraPharma
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP