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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01112059 |
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Date of registration:
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20/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
DOXY |
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Scientific title:
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A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01112059 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Amit Gaggar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cystic Fibrosis
- Hospitalization for Pulmonary exacerbation
Exclusion Criteria:
- Significant GI illness
- Participation in another Investigational Protocol
- Allergies to Doxycycline
- Sputum Culture only positive for Staphylococcus aureus,
- Pregnant or Nursing
- Unwilling to use effective birth control
- Elevated LFT's greater than 3x the upper limit of normal
- Creatinine greater than 1.5x the upper limit of normal
- Lung transplantation
- Substance abuse within 30 days of screening
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Doxycycline
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Other: placebo
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Primary Outcome(s)
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Number of Adverse Events
[Time Frame: 1 month from enrollment]
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Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum
[Time Frame: 8 days past baseline]
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Secondary Outcome(s)
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Mean Change in Pulmonary Function Over Treatment Duration
[Time Frame: Baseline to end of inpatient clinical exacerbation (average 14 days)]
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Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
[Time Frame: 8 days]
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Secondary ID(s)
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F081024004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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