PeriodontitisPhase 4NCT00668746
Long-term Safety of Minocycline in Patients With Gum Disease
A Phase 4 study testing Minocycline HCl microspheres in people with Periodontitis, run by OraPharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Minocycline HCl microspheres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Minocycline HCl microspheres
- Keywords
- chronic periodontitis, antibiotic resistance
- Medical subject headings
- Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline HCl microspheresDrug
Also called minocycline
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.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline HCl microspheres | Experimental | Minocycline HCl microspheres Receives: Drug: Minocycline HCl microspheres |
| No drug intervention | No intervention | No drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Measured: from Baseline to Day 30 and Day 180
Secondary outcomes (2)
Micocycline-Resistance From Plaque Samples
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
Measured: Baseline, Day 30 and Day 180
Micocycline-Resistance From Saliva Sample
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
Measured: Baseline, Day 30 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- OraPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lynch, DMD, PhD, Study director, OraPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668746
- Sponsor's protocol ID
- OP-P-5756-1
- Status last verified
- Dec 2011
- First submitted
- 24 Apr 2008
- Last updated
- 12 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT00668746
- Acronym / sponsor ID
- OP-P-5756-1
- Conditions
- Periodontitis
- Keywords
- chronic periodontitis, antibiotic resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- OraPharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 16 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline HCl microspheres | Experimental | Drug: Minocycline HCl microspheresMinocycline HCl microspheres |
| No drug intervention | No intervention | –No drug intervention |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- generally healthy
- over 25 years of age
- moderate-to-severe chronic periodontitis
- documented informed consent
- willing to comply with contraceptive requirements
Key exclusion criteria (11 listed)
- 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:
- participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline HCl microspheresAlso: minocyclineAt 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. | Drug | Minocycline HCl microspheres |
Primary outcome
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Time frame: from Baseline to Day 30 and Day 180
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
2 secondary outcomes
Micocycline-Resistance From Plaque Samples
Time frame: Baseline, Day 30 and Day 180
Micocycline-Resistance From Saliva Sample
Time frame: Baseline, Day 30 and Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lynch, DMD, PhD study director
OraPharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline HCl microspheres in people with Periodontitis, run by OraPharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture (time frame: from Baseline to Day 30 and Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.