Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)
This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: February 14, 2013
Last verified: January 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 10, 2009 | ||||
| Last Updated Date | February 14, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Occurrence of adverse events after Topotecan administration [ Time Frame: 9months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Occurrence of adverse events after Hycamtin administration [ Time Frame: 9months ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01037023 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Occurrence of unexpected or serious adverse event after Topotecan administration and effectiveness of Topotecan [ Time Frame: 9months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Regulatory Hycamtin(Oral) PMS | ||||
| Official Title ICMJE | 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 |
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| 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 ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients administrated Topotecan at the site |
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| Condition ICMJE | Lung Cancer, Small Cell | ||||
| Intervention ICMJE | Drug: Topotecan
patients administrated Topotecan according to the prescribing information |
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| Study Group/Cohort (s) | Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
Intervention: Drug: Topotecan |
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| Publications * | Not Provided | ||||
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* 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 780 | ||||
| Estimated Completion Date | February 2015 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Eligibility Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01037023 | ||||
| Other Study ID Numbers ICMJE | 113946 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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