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

Tracking Information

First Received Date ^ICMJE

December 10, 2009

Last Updated Date

April 14, 2015

Start Date ^ICMJE

October 2010

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurrence of adverse events after Topotecan administration [ Time Frame: 9 months ]

Original Primary Outcome Measures ^ICMJE

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 ^ICMJE

Occurrence of unexpected adverse event or adverse drug reaction [ Time Frame: 9 months ]
Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ]

Original Secondary Outcome Measures ^ICMJE

Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ]

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

Detailed Description

Topotecan will be administered as described the prescribing information or by physician's decision.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients administrated Topotecan at the site

Condition ^ICMJE

Lung Cancer, Small Cell

Intervention ^ICMJE

Drug: Topotecan

patients administrated Topotecan according to the prescribing information

Study Groups/Cohorts

Patients administrated Topotecan

There is only one group. This group includes patients administrated Topotecan

Intervention: Drug: Topotecan

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2014

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01037023

Other Study ID Numbers ^ICMJE

113946

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

PRS Account

GlaxoSmithKline

Verification Date

April 2015

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

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