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Long-term Safety of Minocycline in Patients With Gum Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668746
First Posted: April 29, 2008
Last Update Posted: December 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OraPharma
Results First Submitted: February 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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



Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT00668746     History of Changes
Other Study ID Numbers: OP-P-5756-1
First Submitted: April 24, 2008
First Posted: April 29, 2008
Results First Submitted: February 26, 2010
Results First Posted: March 16, 2010
Last Update Posted: December 12, 2011