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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
Results First Received: February 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Periodontitis
Intervention: Drug: Minocycline HCl microspheres

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Minocycline HCl Microspheres A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
No Drug Intervention A control consisting of no drug intervention

Participant Flow:   Overall Study
    Minocycline HCl Microspheres     No Drug Intervention  
STARTED     23     12  
COMPLETED     21     11  
NOT COMPLETED     2     1  
Lost to Follow-up                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Minocycline HCl Microspheres A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
No Drug Intervention A control consisting of no drug intervention
Total Total of all reporting groups

Baseline Measures
    Minocycline HCl Microspheres     No Drug Intervention     Total  
Number of Participants  
[units: participants]
  23     12     35  
Age  
[units: years]
Mean ± Standard Deviation
  57.65  ± 10.71     52.83  ± 9.90     56.00  ± 10.55  
Gender  
[units: participants]
     
Female     9     2     11  
Male     14     10     24  
Region of Enrollment  
[units: participants]
     
United States     23     12     35  



  Outcome Measures
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1.  Primary:   Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture   [ Time Frame: from Baseline to Day 30 and Day 180 ]

2.  Secondary:   Micocycline-Resistance From Plaque Samples   [ Time Frame: Baseline, Day 30 and Day 180 ]

3.  Secondary:   Micocycline-Resistance From Saliva Sample   [ Time Frame: Baseline, Day 30 and Day 180 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance
Organization: OraPharma
phone: 215-420-4064
e-mail: bpatel@orapharma.com


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