Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

August 20, 2013 updated by: GlaxoSmithKline

An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
760

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • GSK Clinical Trials Call Center
      • Vienna, Austria, A-1130
        • GSK Clinical Trials Call Center
      • Vienna, Austria, A-1140
        • GSK Clinical Trials Call Center
  • Belgium
      • Charleroi, Belgium, 6000
        • GSK Clinical Trials Call Center
      • Edegem, Belgium, 2650
        • GSK Clinical Trials Call Center
      • Haine-Saint- Paul, Belgium, 7100
        • GSK Clinical Trials Call Center
      • Leuven, Belgium, 3000
        • GSK Clinical Trials Call Center
      • Liege, Belgium, 4000
        • GSK Clinical Trials Call Center
      • Luxembourg, Belgium, 1210
        • GSK Clinical Trials Call Center
  • Brazil
      • Belo Horizonte, Brazil, 30140-083
        • GSK Clinical Trials Call Center
      • Caxias do Sul, Brazil, 95010-060
        • GSK Clinical Trials Call Center
      • Fortaleza, Brazil, 60430-230
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brazil, 90020-090
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brazil, 90035-003
        • GSK Clinical Trials Call Center
      • Rio de Janeiro, Brazil, 20230-130
        • GSK Clinical Trials Call Center
      • Salvador, Brazil, 41920-000
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brazil, 04023-062
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brazil, 05403-900
        • GSK Clinical Trials Call Center
  • Bulgaria
      • Bourgas, Bulgaria, 8000
        • GSK Clinical Trials Call Center
      • Plovdiv, Bulgaria, 4000
        • GSK Clinical Trials Call Center
      • Sofia, Bulgaria, 1000/1527
        • GSK Clinical Trials Call Center
      • Sofia, Bulgaria, 1156
        • GSK Clinical Trials Call Center
      • Varna, Bulgaria, 9010
        • GSK Clinical Trials Call Center
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • GSK Clinical Trials Call Center
      • Edmonton, Alberta, Canada, T6G 1E2
        • GSK Clinical Trials Call Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • GSK Clinical Trials Call Center
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • GSK Clinical Trials Call Center
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • GSK Clinical Trials Call Center
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Clinical Trials Call Center
      • Ottawa, Ontario, Canada, K1H 1C4
        • GSK Clinical Trials Call Center
      • Peterborough, Ontario, Canada, K9H 7B6
        • GSK Clinical Trials Call Center
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • GSK Clinical Trials Call Center
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • GSK Clinical Trials Call Center
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Clinical Trials Call Center
      • Weston, Ontario, Canada, M9N 1N8
        • GSK Clinical Trials Call Center
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H1T 2M4
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H2L 4M1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Clinical Trials Call Center
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Clinical Trials Call Center
  • Chile
      • Santiago, Chile
        • GSK Clinical Trials Call Center
  • China
      • Beijing, China, 100036
        • GSK Clinical Trials Call Center
      • Shanghai, China, 200433
        • GSK Clinical Trials Call Center
      • Wangfujing, China, 100730
        • GSK Clinical Trials Call Center
      • Xian, China, 710061
        • GSK Clinical Trials Call Center
  • Costa Rica
      • San Jose, Costa Rica
        • GSK Clinical Trials Call Center
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • GSK Clinical Trials Call Center
      • Olomouc, Czech Republic, 775 25
        • GSK Clinical Trials Call Center
      • Plzen, Czech Republic, 305 99
        • GSK Clinical Trials Call Center
      • Praha, Czech Republic, 121 00
        • GSK Clinical Trials Call Center
      • Praha, Czech Republic, 150 05
        • GSK Clinical Trials Call Center
  • Estonia
      • Tallinn, Estonia, 11619
        • GSK Clinical Trials Call Center
  • Finland
      • Helsinki, Finland, 29
        • GSK Clinical Trials Call Center
      • Kangasala, Finland, 36280
        • GSK Clinical Trials Call Center
      • Oulu, Finland, 90029
        • GSK Clinical Trials Call Center
  • France
      • Caen, France, 14076
        • GSK Clinical Trials Call Center
      • Calais Cedex, France, 62107
        • GSK Clinical Trials Call Center
      • Strasbourg, France, 67091
        • GSK Clinical Trials Call Center
      • Vesoul, France, 70014
        • GSK Clinical Trials Call Center
  • Germany
      • Grosshansdorf, Germany, 22927
        • GSK Clinical Trials Call Center
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • GSK Clinical Trials Call Center
    • Bayern
      • Ebensfeld, Bayern, Germany, 96250
        • GSK Clinical Trials Call Center
      • Gauting, Bayern, Germany, 82131
        • GSK Clinical Trials Call Center
  • Honduras
      • Tegucigalpa, Honduras
        • GSK Clinical Trials Call Center
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Clinical Trials Call Center
      • Hungary, Hungary, 8900
        • GSK Clinical Trials Call Center
  • Italy
      • Lazio, Italy, 149
        • GSK Clinical Trials Call Center
      • Roma, Italy, 149
        • GSK Clinical Trials Call Center
      • Roma, Italy, 184
        • GSK Clinical Trials Call Center
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Clinical Trials Call Center
  • Jamaica
      • Kingston, Jamaica
        • GSK Clinical Trials Call Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • GSK Clinical Trials Call Center
      • Seoul, Korea, Republic of, 120-752
        • GSK Clinical Trials Call Center
  • Lithuania
      • Kaunas, Lithuania, LT-45434
        • GSK Clinical Trials Call Center
      • Vilnius, Lithuania, LT-08660
        • GSK Clinical Trials Call Center
  • Mexico
      • Chihuahua, Mexico, 31000
        • GSK Clinical Trials Call Center
      • Guadalajara, Mexico, 44280
        • GSK Clinical Trials Call Center
      • Guadalajara, Mexico, 45170
        • GSK Clinical Trials Call Center
      • Mexico City, Mexico, 14000
        • GSK Clinical Trials Call Center
  • Netherlands
      • Apeldoorn, Netherlands, 7334 DZ
        • GSK Clinical Trials Call Center
      • Arnheim, Netherlands, 6815 AD
        • GSK Clinical Trials Call Center
      • Ede, Netherlands, 6716 RP
        • GSK Clinical Trials Call Center
      • Harderwijk, Netherlands, 3844 DG
        • GSK Clinical Trials Call Center
      • Nieuwegein, Netherlands, 3435 CM
        • GSK Clinical Trials Call Center
  • New Zealand
      • Hamilton, New Zealand, 2001
        • GSK Clinical Trials Call Center
      • Wellington South, New Zealand, 6002
        • GSK Clinical Trials Call Center
  • Norway
      • Oslo, Norway, 407
        • GSK Clinical Trials Call Center
  • Panama
      • Panama, Panama
        • GSK Clinical Trials Call Center
  • Poland
      • Gdansk, Poland, 80-211
        • GSK Clinical Trials Call Center
      • Kielce, Poland, 25-640
        • GSK Clinical Trials Call Center
  • Puerto Rico
      • Ponce, Puerto Rico, 716
        • GSK Clinical Trials Call Center
  • Russian Federation
      • Moscow, Russian Federation, 107 055
        • GSK Clinical Trials Call Center
      • Moscow, Russian Federation, 115 478
        • GSK Clinical Trials Call Center
      • Moscow Region, Russian Federation, 143 423
        • GSK Clinical Trials Call Center
  • Singapore
      • Singapore, Singapore, 119074
        • GSK Clinical Trials Call Center
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • GSK Clinical Trials Call Center
      • Bratislava, Slovakia, 825 56
        • GSK Clinical Trials Call Center
      • Kosice, Slovakia, 041 09
        • GSK Clinical Trials Call Center
      • Nitra, Slovakia, 949 88
        • GSK Clinical Trials Call Center
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • GSK Clinical Trials Call Center
  • Spain
      • Lerida, Spain, 25198
        • GSK Clinical Trials Call Center
      • Valencia, Spain, 46009
        • GSK Clinical Trials Call Center
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Clinical Trials Call Center
      • Taipei, Taiwan, 105
        • GSK Clinical Trials Call Center
  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • GSK Clinical Trials Call Center
      • Leeds, United Kingdom, LS16 6QB
        • GSK Clinical Trials Call Center
      • Leicester, United Kingdom, LE1 5WW
        • GSK Clinical Trials Call Center
      • Poole, United Kingdom, BH15 2JB
        • GSK Clinical Trials Call Center
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
        • GSK Clinical Trials Call Center
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • GSK Clinical Trials Call Center
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • GSK Clinical Trials Call Center
    • California
      • Chula Vista, California, United States, 91911
        • GSK Clinical Trials Call Center
      • Fountain Valley, California, United States, 92708
        • GSK Clinical Trials Call Center
      • Greenbrae, California, United States, 94904
        • GSK Clinical Trials Call Center
      • Poway, California, United States, 92064
        • GSK Clinical Trials Call Center
      • Rancho Mirage, California, United States, 92270
        • GSK Clinical Trials Call Center
      • Sacramento, California, United States, 95816-5616
        • GSK Clinical Trials Call Center
      • San Diego, California, United States, 92102-8421
        • GSK Clinical Trials Call Center
      • San Diego, California, United States, 92121
        • GSK Clinical Trials Call Center
      • Soquel, California, United States, 95073
        • GSK Clinical Trials Call Center
      • Vista, California, United States, 92083
        • GSK Clinical Trials Call Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • GSK Clinical Trials Call Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • GSK Clinical Trials Call Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5001
        • GSK Clinical Trials Call Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • GSK Clinical Trials Call Center
      • Miami Shores, Florida, United States, 33138
        • GSK Clinical Trials Call Center
      • Ocala, Florida, United States, 34471
        • GSK Clinical Trials Call Center
      • Pensacola, Florida, United States, 32501
        • GSK Clinical Trials Call Center
      • Tarpon Springs, Florida, United States, 34689
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30030
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, United States, 30308
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, United States, 30328
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, United States, 30335
        • GSK Clinical Trials Call Center
      • Augusta, Georgia, United States, 30912
        • GSK Clinical Trials Call Center
      • Cummings, Georgia, United States, 30040
        • GSK Clinical Trials Call Center
      • Decatur, Georgia, United States, 30033
        • GSK Clinical Trials Call Center
    • Illinois
      • Aurora, Illinois, United States, 60506
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, United States, 60612
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, United States, 60637-1470
        • GSK Clinical Trials Call Center
      • Elk Grove Village, Illinois, United States, 60007
        • GSK Clinical Trials Call Center
      • Park Ridge, Illinois, United States, 60068
        • GSK Clinical Trials Call Center
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Clinical Trials Call Center
      • South Bend, Indiana, United States, 46601
        • GSK Clinical Trials Call Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Clinical Trials Call Center
      • Shreveport, Louisiana, United States, 71103
        • GSK Clinical Trials Call Center
    • Maryland
      • Frederick, Maryland, United States, 21701
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • GSK Clinical Trials Call Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • GSK Clinical Trials Call Center
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Clinical Trials Call Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • GSK Clinical Trials Call Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • GSK Clinical Trials Call Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • GSK Clinical Trials Call Center
    • New York
      • Albany, New York, United States, 12208
        • GSK Clinical Trials Call Center
      • New York, New York, United States, 10021
        • GSK Clinical Trials Call Center
      • New York, New York, United States, 10032
        • GSK Clinical Trials Call Center
      • Rochester, New York, United States, 14623
        • GSK Clinical Trials Call Center
      • Valhalla, New York, United States, 10595
        • GSK Clinical Trials Call Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • GSK Clinical Trials Call Center
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • GSK Clinical Trials Call Center
      • Columbus, Ohio, United States, 43222
        • GSK Clinical Trials Call Center
    • Oregon
      • Portland, Oregon, United States, 97232-2099
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Lemoyne, Pennsylvania, United States, 17043
        • GSK Clinical Trials Call Center
      • Limerick, Pennsylvania, United States, 19468
        • GSK Clinical Trials Call Center
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Clinical Trials Call Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • GSK Clinical Trials Call Center
      • Spartanburg, South Carolina, United States, 29303
        • GSK Clinical Trials Call Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • GSK Clinical Trials Call Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • GSK Clinical Trials Call Center
      • Houston, Texas, United States, 77060
        • GSK Clinical Trials Call Center
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • GSK Clinical Trials Call Center
      • Norfolk, Virginia, United States, 23502
        • GSK Clinical Trials Call Center
    • Washington
      • Olympia, Washington, United States, 98506
        • GSK Clinical Trials Call Center
      • Yakima, Washington, United States, 98902
        • GSK Clinical Trials Call Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • GSK Clinical Trials Call Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Clinical Trials Call Center
    • Wyoming
      • Laramie, Wyoming, United States, 82070
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent (patient's written understanding of and agreement to participate in this study).
  • Patients with confirmed extensive small cell lung cancer (SCLC).
  • No prior chemotherapy within 5 years of the diagnosis of SCLC.
  • Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
  • At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

  • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
  • Any active infection.
  • Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
  • Use of an investigational drug within 30 days before the first dose of study medication.
  • Women who are pregnant or lactating.
  • Patients of child-bearing potential who refuse to practice an adequate form of birth control.
  • Patients with clinical evidence of any stomach or intestinal (GI) condition.
  • Patients requiring treatment with the drug cyclosporin A.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Overall Survival

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 104864-A/389

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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