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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: |
NCT02602509 |
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Date of registration:
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06/11/2015 |
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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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Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers
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Scientific title:
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Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02602509 |
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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: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Nicholas Paton |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Hospital, Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Aged over 21 years and below 60 years old
2. Male or female willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent
Exclusion Criteria:
1. Women who are currently pregnant or breastfeeding
2. Body weight below 50kg
3. Clinical signs of active TB in the opinion of the investigator
4. Previous hypersensitivity, intolerance or allergy to rifampicin, pyrazinamide, COX-2
inhibitors, non-steroidal anti-inflammatory drugs or sulfonamides
5. Current use of any drugs or medication known to have an interaction with rifampicin,
pyrazinamide or celecoxib
6. Current use or use in the last 2 weeks of non-steroidal anti-inflammatory drugs or
COX-2 inhibitors
7. Current use or use in the last 2 weeks of any drugs, over the counter or herbal
preparations that are known or potential inhibitors or inducers of cytochrome P450
enzymes
8. Evidence of renal or hepatic dysfunction or any clinically significant deviation from
normal during screening including laboratory determinations
9. Known hepatic disease, recent hepatitis (within last 6 months) or alcohol abuse
10. Known cardiovascular disease, heart failure, stroke or current cardiovascular risk
factors
11. Known peptic ulcer disease, previous gastrointestinal bleed or current risk factors
for gastrointestinal events
12. Acute or previous gout, acute porphyria
13. Any other significant condition that would, in the opinion of the investigator,
compromise the volunteer's safety or outcome in the trial
14. Current participation in other clinical intervention trial or research protocol
Age minimum:
21 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Drug: Rifampicin
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Drug: Pyrazinamide
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Drug: Celecoxib
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Primary Outcome(s)
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Log change CFU.day (cumulative over 8 hours) calculated from Mycobacteria Growth Indicator Tube (MGIT) Time to Positivity
[Time Frame: 8 hours]
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Secondary Outcome(s)
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Plasma concentrations of study drugs to determine the Area Under the Curve (AUC)
[Time Frame: 8 hours]
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Plasma concentrations of study drugs to determine the Maximum Plasma Concentration (Cmax)
[Time Frame: 8 hours]
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Secondary ID(s)
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Celecoxib_WBA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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