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
  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 4

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


Further study details as provided by OraPharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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
Experimental: Minocycline HCl microspheres
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.
Other Name: minocycline
No Intervention: No drug 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
OraPharma
Investigators
Study Director: Michael Lynch, DMD, PhD OraPharma
  More Information

No publications provided

Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT00668746     History of Changes
Other Study ID Numbers: OP-P-5756-1
Study First Received: April 24, 2008
Results First Received: February 26, 2010
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by OraPharma:
chronic periodontitis, antibiotic resistance

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014