A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
ANDANTE
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
3 other identifiers
interventional
250
18 countries
193
Brief Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
Typical duration for phase_2
193 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
First Submitted
Initial submission to the registry
January 31, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
January 21, 2016
CompletedJanuary 21, 2016
December 1, 2015
3.6 years
January 31, 2011
September 14, 2015
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (\>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Baseline and Week 8
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.
Baseline and Week 8
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Baseline and Week 12
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.
Baseline and Week 12
Secondary Outcomes (12)
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Baseline and Weeks 2, 4, 6, and 10
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Baseline and Weeks 2, 4, 6, and 10
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Baseline and Weeks 2, 4, 6, 8, 10, and 12
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Baseline and Weeks 2, 4, 6, 8, 10, and 12
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Baseline and Weeks 2, 4, 6, 8, 10, and 12
- +7 more secondary outcomes
Study Arms (3)
Placebo- SC injection
PLACEBO COMPARATORDrug Dose level 1 - SC injection
EXPERIMENTALDrug Dose level 2 - SC injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects must have failed or are intolerant to anti TNFs
- hsCRP greater or equal to 5.0 mg/L
- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening
You may not qualify if:
- Pregnant or breastfeeding women
- Crohn's Disease with active fistulae or abscess
- History of diverticulitis or symptomatic diverticulosis
- Abnormality in hematology or chemistry profiles at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (193)
UAB Hospital
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Simon Medical Imaging
Scottsdale, Arizona, 85258, United States
Digestive Health Research Unit
Scottsdale, Arizona, 85260, United States
Adobe Clinical Research, Llc
Tucson, Arizona, 85712, United States
Radiology Ltd
Tucson, Arizona, 85712, United States
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, 94115, United States
University of California - San Francisco
San Francisco, California, 94115, United States
University of California San Francisco at Mount Zion
San Francisco, California, 94115, United States
Rocky Mountain Clinical Research, LLC
Denver, Colorado, 80222, United States
Rocky Mountain Gastroenterology Associates
Lakewood, Colorado, 80215, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80215, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, 80120, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, 06437, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, 06518, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Gastroenterology Associates
Crystal River, Florida, 34429, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Suncoast Endoscopy Center
Inverness, Florida, 34453, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653, United States
International Clinical Research - US, LLC
Sanford, Florida, 32771, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Atlanta Endoscopy Center
Decatur, Georgia, 30033, United States
Decatur Health Imaging
Decatur, Georgia, 30033, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
GI Diagnostics
Marietta, Georgia, 30067, United States
Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois, 60005, United States
The University of Chicago Medical Center (Ucmc)
Chicago, Illinois, 60637, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
The University of Chicago Medical
Chicago, Illinois, 60637, United States
The University Of Chicago
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois, 60025, United States
Glenbrook Hospital
Glenview, Illinois, 60026, United States
Central Indiana Gastroenterology Group
Anderson, Indiana, 46016, United States
Saint John's Research Institute
Anderson, Indiana, 46016, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University Of Louisville Healthcare Outpatient Center
Louisville, Kentucky, 40202, United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Disgestive Disorders Associates
Annapolis, Maryland, 21401, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland, 21401, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Prima CARE, PC
Fall River, Massachusetts, 02721, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
East Valley Endoscopy
Grand Rapids, Michigan, 49546, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519, United States
Metro Health Hospital Endoscopy Unit
Wyoming, Michigan, 49519, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
Minnesota Gastroenterology, PA
Plymouth, Minnesota, 55446, United States
Weill Cornell Medical College of Cornell University-Greenberg
New York, New York, 10021, United States
Weill Cornell Medical College of Cornell University
New York, New York, 10021, United States
Present Chapman, Steinlauf and Marion
New York, New York, 10028, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
New York, New York, 10065, United States
New York Presbyterian Hospital
New York, New York, 10065, United States
Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York, 10065, United States
Arthur asher Kornbluth, MD PC
New York, New York, 10128, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73102, United States
Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma, 73103, United States
Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma, 73104, United States
Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma, 74104, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74104, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Utica Park Clinic X-Ray
Tulsa, Oklahoma, 74104, United States
Advanced Imaging
Tulsa, Oklahoma, 74137-4200, United States
Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania, 15243, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Professional Quality Research, Inc.
Austin, Texas, 78705, United States
Diagnostic Clinic of Houston, PA
Houston, Texas, 77004, United States
Houston Hospital for Specialized Surgery (Endoscopy Only)
Houston, Texas, 77004, United States
Baylor Clinic (Drug Storage)
Houston, Texas, 77030, United States
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, 77030, United States
Ertan Digestive Disease Center
Houston, Texas, 77030, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The University of Texas Medical School at Houston
Houston, Texas, 77030, United States
Physicians Endoscopy Center (Colonoscopy)
Houston, Texas, 77036, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
One Step Diagnostic (X-Ray)
Sugar Land, Texas, 77478, United States
Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas, 77479, United States
Pioneer Research Solutions, Inc.
SugarLand, Texas, 77479, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
University Of Utah HSC
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0341, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia, 93298-5028, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Public Hospital
Kingswood, New South Wales, 2747, Australia
Royal Brisbane and Women's Hospital
Herston, Brisbane, Queensland, 4029, Australia
Mater Health Services
South Brisbane, Queensland, 4101, Australia
Eastern Health, Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
St. Vincent's Hospital Melbourne
Fitzroy, VIC 3065, Australia
University Hospital Leuven
Leuven, Vlaams Brabant, 3000, Belgium
CHU Saint-Pierre
Brussels, 1000, Belgium
UZ Leuven Pharmacy
Leuven, 3000, Belgium
An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, B-8800, Belgium
Clinica do Coracao Samaritano
Goiânia, Goiás, 74535-170, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
Goiânia, Goiás, 74535-170, Brazil
Center X Diagnosticos
Goiânia, Goiás, 74535-900, Brazil
Hospital Universitário Fraga Filho da UFRJ
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901, Brazil
Hospital Nossa Senhora das Gracas
Curitiba, 80810-040, Brazil
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
London Health Science Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Klinicke centrum ISCARE I.V.F. - gastroenterologie
Prague, Prague, 170 04, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
Medial Pharma s.r.o.,
Hradec Králové, 500 12, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
IBD Clinical and Research centre
Prague, Czechia
Krajska zdravotni, a.s.
Ústí nad Labem, 40113, Czechia
Aalborg Sygehus
Aalborg, 9100, Denmark
Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital
Aarhus C, 8000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Gastroenheden
Herlev, 2730, Denmark
Kirurgisk Afdeling 0143
Hilleroed, 3400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Afdeling I, Gastroenterologisk Sektion
Koebenhavn NV, 2400, Denmark
Medicinsk Afdeling, Gastroenterologisk Sektion
Koege, 4600, Denmark
Hopital Huriez, CHRU de Lille
Lille, 59037, France
Hopital Saint-Antoine - Service De Gastroenterologie
Paris, 75571, France
Hopital de Brabois
Vandœuvre-lès-Nancy, 54500, France
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
"Charite - Campus Benjamin Franklin
Berlin, 12200, Germany
Praxis Dr. Howaldt
Hamburg, 20148, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Universitaetsklinik Regensburg
Regensburg, 93053, Germany
University General Hospital "Attikon"
Athens, 12462, Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, 106 76, Greece
Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
Szeged, 6720, Hungary
Clinfan Kft.
Szekszárd, 7100, Hungary
Beaumont Hospital
Dublin, 9, Ireland
National Virus Reference Laboratory
Dublin, Dublin 4, Ireland
Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group
Dublin, Dublin 4, Ireland
Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
Dublin, Dublin 7, Ireland
St. Vincents University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
The Institute Of Gastroenterology & Liver Diseases
Tel Litwinsky, Ramat Gan, 52621, Israel
Institute of Gastroenterology
Haifa, 3339419, Israel
The E. Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Dept of Gastroenterology & Hepatology
Kfar Saba, 44281, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva
San Giovanni Rotondo Fg, Foggia, 71013, Italy
Istituto Clinico Humanitas IRCCS
Rozzano, Milano, 20089, Italy
Azienda Ospedaliera - Universita di Padova
Padua, Padova, 35128, Italy
A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and
Rome, Province of Rome, 00168, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Università Campus Biomedico
Roma, 00128, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00151, Italy
Shakespeare Specialist Group
Milford, Auckland, 0620, New Zealand
Christchurch Hospital
Christchurch, Canterbury, 8011, New Zealand
Department of Gastroenterology Research
Hamilton, Waikato Region, 3204, New Zealand
P3 Research Limited
Wellington, 6021, New Zealand
Spitalul Clinic Colentina
Bucharest, Sector 2, 020125, Romania
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Hull and East Yorkshire Hospitals NHS Trust
Hull, East Yorkshire, HU3 2JZ, United Kingdom
Addenbrooke's Hospital, Department of Gastroenterology
Cambridge, CB2 0QQ, United Kingdom
Glasgow Royal Infirmary
Glasgow, G40SS, United Kingdom
Pharmacy Department
Hull, HU3 2JZ, United Kingdom
Barts and The London NHS Trust
London, E1 1BB, United Kingdom
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, NW3 2QG, United Kingdom
Royal Victoria Hospital
Newcastle upon Tyne, NE1 4LP, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV69AT, United Kingdom
Related Publications (2)
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
PMID: 29776017DERIVEDDanese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.
PMID: 29247068DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Enrollment into the 200 mg arm was halted on 14 August 2013 before reaching the planned sample size due to safety findings in NCT01405196. Hence the 200 mg vs placebo comparisons were excluded from the primary analyses and reported separately.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 2, 2011
Study Start
February 1, 2011
Primary Completion
September 1, 2014
Study Completion
February 1, 2015
Last Updated
January 21, 2016
Results First Posted
January 21, 2016
Record last verified: 2015-12