Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
![]() |
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01364324 |
Recruitment Status
:
Recruiting
First Posted
: June 2, 2011
Last Update Posted
: April 13, 2017
|
Sponsor:
National Cancer Center, Korea
Information provided by (Responsible Party):
Hee Seok Lee, National Cancer Center, Korea
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | May 23, 2011 | ||||
First Posted Date | June 2, 2011 | ||||
Last Update Posted Date | April 13, 2017 | ||||
Study Start Date | September 2010 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
The change in the maximum concentration (Cmax) of first-line TB drugs [ Time Frame: Before and 1, 2, 4, 6 and 8 hours after dosing ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT01364324 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures |
The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug [ Time Frame: 9month after anti-TB treatment ] Treatment duration can be varied according to several factors such as a first TB episode or not, cavitary TB, and AFB culture(+) after 2month-treatment etc. We will plan 6 or 9 months treatment for each patient according to these factors. During treatment period, we will check chest radiographs and sputum AFB smear/culture with every 2-3month intervals. At 9month after treatment, we will evaluate the effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug by taking account of improvement on chest radiograph and negative conversion and its continuation on sputum smear/culture.
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients | ||||
Official Title | Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients | ||||
Brief Summary | The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB). | ||||
Detailed Description | Gastrectomy is a well-known risk factor for TB. Also, there were some reports about malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of recently used first line anti-TB drugs in the gastrectomized patients have not been well evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary TB through this study. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years) | ||||
Condition |
|
||||
Intervention | Drug: standard first line anti-TB drugs
We will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB
Other Name: Pharmacokinetics of Anti-tuberculosis Drugs |
||||
Study Groups/Cohorts |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
40 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 2019 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years to 80 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
||||
Listed Location Countries | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01364324 | ||||
Other Study ID Numbers | NCCCTS-10-493 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Hee Seok Lee, National Cancer Center, Korea | ||||
Study Sponsor | National Cancer Center, Korea | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | National Cancer Center, Korea | ||||
Verification Date | April 2017 |