Long-term Safety of Minocycline in Patients With Gum Disease

NCT00668746 | Completed Phase 4 Results

• 1 other identifier: OP-P-5756-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis

Keywords

chronic periodontitis, antibiotic resistance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Micocycline-Resistance From Plaque Samples

  Baseline, Day 30 and Day 180

• Micocycline-Resistance From Saliva Sample

  Baseline, Day 30 and Day 180

Study Arms (2)

Minocycline HCl microspheres

EXPERIMENTAL

Minocycline HCl microspheres

Drug: Minocycline HCl microspheres

No drug intervention

NO INTERVENTION

No drug intervention

Interventions

Minocycline HCl microspheres DRUG

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.

Also known as: minocycline

Minocycline HCl microspheres

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• willing to adhere to prohibitions and restrictions of the study
• 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

Sponsors & Collaborators

• OraPharma: lead

Study Sites (1)

Forsyth Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance
• Organization: OraPharma

bpatel@orapharma.com

215-420-4064

Study Officials

• Michael Lynch, DMD, PhD

  OraPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 12, 2011
• Results First Posted: March 16, 2010

Record last verified: 2011-12

Locations

US (1)