An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy
1 other identifier
interventional
1,455
15 countries
172
Brief Summary
NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedResults Posted
Study results publicly available
November 26, 2014
CompletedNovember 26, 2014
November 1, 2014
1.6 years
April 19, 2011
November 6, 2014
November 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
25-120 hours
Secondary Outcomes (2)
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
0-24 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
0-120 hours
Study Arms (4)
Netupitant and Palonosetron+dexamethasone-cycle 1
EXPERIMENTALOral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron+dexamethasone-cycle 1
ACTIVE COMPARATOROral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron+dexamethasone-multicycle extension
EXPERIMENTALOral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron+dexamethasone-multicycle extension
ACTIVE COMPARATOROral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Interventions
Eligibility Criteria
You may qualify if:
- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
- Scheduled to receive first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid malignant tumor: cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. doxorubicin (more or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (more or equal to 60 mg/m2).
- If scheduled to receive chemotherapy agents of minimal to low emetogenic potential they could be given on any day.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial
- Hematologic and metabolic status adequate for receiving a moderately emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
- Participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator Satisfactory study compliance in the preceding cycle of chemotherapy and related study procedures.
- Scheduled to receive the same chemotherapy regimen as cycle 1
- Adequate hematologic and metabolic status as defined for cycle 1
You may not qualify if:
- If female, pregnant or lactating.
- Current use of illicit drugs or current evidence of alcohol abuse.
- Scheduled to receive any highly emetogenic chemotherapy (HEC) from Day 1 to Day 5 or moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed MEC regimen.
- Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1.
- Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
- Symptomatic primary or metastatic central nervous system (CNS) malignancy.
- Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient.
- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or dexamethasone.
- Previously received a neurokin-1 (NK1) receptor antagonist
- Participation in a clinical trial involving oral netupitant administered in combination with palonosetron.
- Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.
- Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1.
- Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
- Any medication with known or potential antiemetic activity within 24 hours prior to Day 1 of cycle 1
- Scheduled to receive any strong or moderate inhibitor of cytocrome P450 3A4 (CYP3A4) or its intake within 1 week prior to Day 1.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinn Healthcare SAlead
- Parexelcollaborator
Study Sites (172)
Anniston Oncology/Regional Medical Center
Anniston, Alabama, 36207, United States
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Genesis Cancer Centre
Hot Springs, Arkansas, 71913, United States
Compassionate Cancer Care Medical Group Inc
Corona, California, 92879, United States
Compassionate Cancer Centre Medical Group
Fountain Valley, California, 92708, United States
American Institute of Research
Los Angeles, California, 90017, United States
Facey Medical Group
Mission Hills, California, 91345, United States
Compassionate Cancer Care Medical Group
Riverside, California, 92501, United States
American Institute of Research
Whittier, California, 90603, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, 47150, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
The John R Marsh Cancer Center
Hagerstown, Maryland, 21742, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01608, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Piedmont Hematology Oncology Associates PA
Winston-Salem, North Carolina, 27103, United States
Tri-County Hematology and Oncolgy Associates Inc.
Massillon, Ohio, 44646, United States
Signal Point Clinical Research Center LLC
Middletown, Ohio, 45042, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29414, United States
Wellmont Medical Associates-Oncology and Hematology
Bristol, Tennessee, 37620, United States
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, 78412, United States
The University of Texas Health Center
Tyler, Texas, 75708, United States
Northern Utah Associates Hematology / Oncology
Ogden, Utah, 84403, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Hospital Italiano de Cordoba
Córdoba, 5000, Argentina
Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)
Córdoba, X5004FHP, Argentina
Instituto Oncológico de Córdoba - Sanatorio Aconcagua
Córdoba, X5006HBF, Argentina
Centro Oncológico Integral (COI)
Mar del Plata, 7600, Argentina
Centro Oncologico de Integracion Regional (COIR)
Mendoza, M5500AYB, Argentina
Instituto Médico CER [Oncology]
Quilmes, B1878DVB, Argentina
Sanatorio Parque
Rosario, S2000DVS, Argentina
Centro Medico San Roque
San Miguel de Tucumán, T4000AIK, Argentina
ISIS Clinica Especializada
Santa Fe, 3000, Argentina
Bobruisk Interregional Oncological Dispensary
Babruysk, 213825, Belarus
Brest Regional Oncological Dispensary
Brest, 224027, Belarus
Gomel Regional Clinical Oncological Dispensary
Brest, 246012, Belarus
Minsk city Clinical Oncological Dispensary [Oncology]
Minsk, 220013, Belarus
State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
Minsk, 223040, Belarus
Mogilev Regional Oncological Dispensary [Oncology]
Mogilev, 212018, Belarus
OXION-Medicina Oncológica
Belo Horizonte, 30150270, Brazil
Centro de Pesquisas Clínicas em Oncologia
Cachoeiro de Itapemirim, 29308-014, Brazil
IPCEM - Centro de Ciências da Saúde - Universidade de Caxias
Caxias do Sul, 95070-560, Brazil
Hospital Araújo Jorge
Goiânia, 74605-070, Brazil
Clinica de Neoplasias do Litoral
ItajaÃ, 88301-220, Brazil
Clinica De Oncologia De Porto Alegre S S Ltda
Porto Alegre, 90430-090, Brazil
Hospital Moinhos de Vento
Porto Alegre, RS90560-030, Brazil
Instituto Ribeirãopretano de Combate ao Cancer
Ribeirão Preto, 14015-130, Brazil
Oncotrat Oncologia Medica Ltda [Oncology]
Rio de Janeiro, 22451010, Brazil
Nucleo de Oncologia da Bahia
Salvador Bahia, 40170-110, Brazil
Hospital Santa Cruz
São Paulo, 04121-000, Brazil
Casa de Saude Santa Marcelina
São Paulo, 08270-070, Brazil
SHATO "Sveti Mina"
Blagoevgrad, 2700, Bulgaria
MHAT Dr. Tota Venkova [Oncology]
Gabrovo, 5300, Bulgaria
Specialized Hospital for Active Treatment of Oncology
Haskovo, 6300, Bulgaria
UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
Pleven, 5800, Bulgaria
UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]
Plovdiv, 4002, Bulgaria
District Dispensery with Stationary - Sofia District
Sofia, 1233, Bulgaria
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
Sofia, 1527, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, 1756, Bulgaria
Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City
Sofia, 1784, Bulgaria
Complex Oncology Centre
Stara Zagora, 6003, Bulgaria
COC - Veliko Tarnovo Dept. Medical Oncology
Veliko Tarnovo, 5000, Bulgaria
Comprehensive Cancer Center - Vratsa Dept. of Palliative Care
Vratsa, 3000, Bulgaria
Županijska bolnica Cakovec
Čakovec, 40000, Croatia
Klinicki bolnicki centar Osijek [Oncology]
Osijek, 31000, Croatia
Opca bolnica Pula [Odjel za onklologiju]
Pula, 52000, Croatia
KBC Rijeka [Gastroenterology]
Rijeka, 51000, Croatia
Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]
Varaždin, 42 000, Croatia
Opca Bolnica Zadal Ulica
Zadar, 23000, Croatia
Klinički bolnički centar Zagreb [Oncology]
Zagreb, 10 000, Croatia
Klinicka bolnica [Sestre milosrdnice]
Zagreb, 10000, Croatia
Klinika za tumore [Odjel za kemoter. i internisticku onkolog
Zagreb, 10000, Croatia
Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
Berlin, 10117, Germany
Gynäkologische Arztpraxis
Berlin, 10317, Germany
OncoResearch Lerchenfeld UG
Hamburg, 22081, Germany
Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert
Mannheim, 68161, Germany
Rotkreuzklinikum [München]
München, 80637, Germany
Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]
München, 81545, Germany
Staedtisches Krankenhaus Muenchen Neuperlach
München, 81737, Germany
OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie
Regensburg, 93053, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Praxis Dr. G. Dresemann
Velen, 46342, Germany
Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr
Weilheim, 82362, Germany
Semmelweis Egyetem Kútvölgyi Klinikai Tömb
Budapest, 1125, Hungary
Fővárosi Önkormányzat Uzsoki utcai Kórház
Budapest, 1145, Hungary
Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt
Győr, 9024, Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi
Kecskemét, 6000, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526, Hungary
Josa Andras Oktato Korhaz [Onkologiai Osztaly]
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Klinikai Köpont
Pécs, 7624, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok, 5004, Hungary
HCG - Multy Speciality Hospital
Ahmedabad, 380006, India
Hemato-Oncology Clinic Ahmedabad Pvt Ltd
Ahmedabad, 380009, India
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
Amravati, 444606, India
Sri Venkateshwara Hospital [Medical Oncology]
Bangalore, 560068, India
Apollo Speciality Hospital
Chennai, 600035, India
Dr. Kamahshi Memorial Hospital [Oncology]
Chennai, 600100, India
BIBI General Hospital & Cancer Centre [Oncology]
Hyderabad, 500 024, India
Yashoda B-Block Hospital
Hyderabad, 500 082, India
B.P.Poddar Hospital and Medical Research Ltd
Kolkata, 700053, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, 700054, India
Shatabdhi Superspeciality Hospital
Nashik, 422005, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, 411001, India
City Cancer Centre [Surgical and Medical Oncology]
Vijayawada, 520002, India
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124, Italy
Ospedale Vito Fazzi, ASL Lecce
Lecce, 73100, Italy
Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco
Lecco, 23900, Italy
Ospedale Sacro Cuore e Don Calabria - Negrar
Negrar, 37024, Italy
Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]
Potenza, 85100, Italy
Centro Oncologico De Chihuahua
Chihuahua City, 31217, Mexico
Hospital de Jesus
México, 06090, Mexico
Centro Medico Quirurgico
México, 20234, Mexico
OCA Hospital/Monterrey International Research Center
Monterrey, 64000, Mexico
Centro Regiomontano de Investigación Clínica
Monterrey, 64710, Mexico
Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie
Bialystok, 15-027, Poland
Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny
Elblag, 82-200, Poland
Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej
Kościerzyna, 83-400, Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, 93-513, Poland
Olsztynski Osrodek Onkologiczny "KOPERNIK"
Olsztyn, 10-513, Poland
Szpital Rejonowy im. dr J. Rostka w Raciborzu
Racibórz, 47-400, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Słupsk, 76-200, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
Warsaw, 02-781, Poland
NZOZ Magodent - Centrum Medczyne Ostrobramska
Warsaw, 04-125, Poland
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
Łomża, 18-400, Poland
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala]
Baia Mare, 430031, Romania
Spitalul Universitar de Urgenta Elias [Oncologie Medicala]
Bucharest, 011461, Romania
Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]
Bucharest, 011464, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]
Bucharest, 22328, Romania
Oncolab - Oncology Center Craiova
Craiova, 200385, Romania
Institutul Regional de Oncologia
Iași, 700483, Romania
Spitalul Municipal Onesti [Sectia Oncologie Medicala]
Onești, 601048, Romania
Spitalul Clinic Judetean Mures
Tg Mures, 0540142, Romania
Oncomed SRL
Timișoara, 300239, Romania
GUZ Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, 163045, Russia
Ivanovo Regional Oncological Dispensary [Chemotherapy]
Ivanovo, 153013, Russia
GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
Kazan', 420029, Russia
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
Krasnoyarsk, 660133, Russia
GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
Lipetsk, 398005, Russia
GUZ Regional Oncology Dispensary #2
Magnitogorsk, 455001, Russia
Russian Cancer Research Center
Moscow, 115478, Russia
SBHI of Moscow City Oncology Clinical Hospital #62
Moscow, 143423, Russia
MBUZ City Clinical Hospital #1
Novosibirsk, 630047, Russia
FGBU Medical Radiology Scientific Center
Obninsk, 249036, Russia
GUZ Perm Regional Oncology Dispensary
Perm, 614066, Russia
GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]
Pyatigorsk, 357502, Russia
GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
Ryazan, 390026, Russia
GUZ "Leningrad Regional Oncology Dispensary"
Saint Petersburg, 188663, Russia
City Oncology Dispensary
Saint Petersburg, 197022, Russia
GOU VPO Saint-Petersburg State Medical University n.a. acad.
Saint Petersburg, 197022, Russia
St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D
Saint Petersburg, 197022, Russia
FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed
Saint Petersburg, 197758, Russia
GUZ Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355047, Russia
GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan
Ufa, 450054, Russia
GUZ Republican Clinical Oncological Dispensary of public
Ufa, 450054, Russia
Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy
Cherkasy, 18009, Ukraine
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
Chernihiv, 14029, Ukraine
Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
Chmelnytskyi, 29009, Ukraine
Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4
Dnipropetrovks, 49102, Ukraine
Donetskyi oblasnyi protypukhlynnyi tsentr
Donetsk, 83092, Ukraine
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
Kharkiv, 61070, Ukraine
Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr
Kyiv, 03115, Ukraine
KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser
Kyiv, 04107, Ukraine
Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr
Lviv, 79031, Ukraine
Odeska oblasna klinichna likarnia
Odesa, 65025, Ukraine
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
Poltava, 36011, Ukraine
Zakarpatskyi oblasnyi klinichnyi onkodyspanser
Uzhhorod, 88014, Ukraine
Related Publications (2)
Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
PMID: 30968588DERIVEDRugo HS, Rossi G, Rizzi G, Aapro M. Efficacy of NEPA (netupitant/palonosetron) across multiple cycles of chemotherapy in breast cancer patients: A subanalysis from two phase III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.
PMID: 28285236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Development
- Organization
- Helsinn Healthcare SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 20, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2012
Last Updated
November 26, 2014
Results First Posted
November 26, 2014
Record last verified: 2014-11