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Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: April 14, 2015
Last verified: April 2015
History of Changes

December 10, 2009
April 14, 2015
October 2010
November 2014   (final data collection date for primary outcome measure)
Occurrence of adverse events after Topotecan administration [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Occurrence of adverse events after Hycamtin administration [ Time Frame: 9months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01037023 on ClinicalTrials.gov Archive Site
  • Occurrence of unexpected adverse event or adverse drug reaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Regulatory Hycamtin(Oral) PMS
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
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

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.
Observational
Not Provided
Not Provided
Not Provided
Probability Sample
Patients administrated Topotecan at the site
Lung Cancer, Small Cell
Drug: Topotecan
patients administrated Topotecan according to the prescribing information
Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
Intervention: Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
November 2014
November 2014   (final data collection date for primary outcome measure)

All subjects must satisfy the following criteria.

  • Subject who is under the indication to the prescribing information of oral Hycamtin.
  • Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.

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.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01037023
113946
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP