Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)
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ClinicalTrials.gov Identifier: NCT01037023 |
Recruitment Status
:
Completed
First Posted
: December 21, 2009
Last Update Posted
: April 15, 2015
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Tracking Information | ||||
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First Submitted Date | December 10, 2009 | |||
First Posted Date | December 21, 2009 | |||
Last Update Posted Date | April 15, 2015 | |||
Study Start Date | October 2010 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Occurrence of adverse events after Topotecan administration [ Time Frame: 9 months ] | |||
Original Primary Outcome Measures |
Occurrence of adverse events after Hycamtin administration [ Time Frame: 9months ] | |||
Change History | Complete list of historical versions of study NCT01037023 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ] | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Regulatory Hycamtin(Oral) PMS | |||
Official Title | An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of HYCAMTIN Administered in Korean Patients According to the Prescribing Information | |||
Brief Summary | Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information | |||
Detailed Description | Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information Topotecan will be administered as described the prescribing information or by physician's decision. |
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Study Type | Observational | |||
Study Design | Not Provided | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients administrated Topotecan at the site | |||
Condition | Lung Cancer, Small Cell | |||
Intervention | Drug: Topotecan
patients administrated Topotecan according to the prescribing information |
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Study Groups/Cohorts | Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
Intervention: Drug: Topotecan |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
92 | |||
Original Estimated Enrollment |
780 | |||
Actual Study Completion Date | November 2014 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | All subjects must satisfy the following criteria.
All subjects must not satisfy the following criteria. • Subject who is under the contraindication to the prescribing information of oral Hycamtin. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea. |
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01037023 | |||
Other Study ID Numbers | 113946 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | GlaxoSmithKline | |||
Study Sponsor | GlaxoSmithKline | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | GlaxoSmithKline | |||
Verification Date | April 2015 |