A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

September 3, 2019 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

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.

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

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 (Actual)

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.
1876

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

  • Argentina
      • Buenos Aires, Argentina, C1414AIF
        • Research Site
      • Caba, Argentina
        • Research Site
      • Caba, Argentina, C1425BEN
        • Research Site
      • Caba, Argentina, C1056ABJ
        • Research Site
      • Caba, Argentina, 1426
        • Research Site
      • Ciudad Autonomade Buenos Aires, Argentina, 1426
        • Research Site
      • Ciudad Autónoma de Buenos Aire, Argentina, C1440BRR
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1425
        • Research Site
      • Concepción del Uruguay, Argentina, 3260
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Florencio Varela, Argentina, 1888
        • Research Site
      • Mar del Plata, Argentina, 7600
        • Research Site
      • Mar del Plata, Argentina, B7600GNY
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      • Mar del Plata, Argentina, B7600FZN
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      • Mendoza, Argentina, 5500
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      • Mendoza, Argentina, M5500GIP
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      • Nueve de julio, Argentina, B6500EZL
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      • Ranelagh, Argentina, 1886
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      • Rosario, Argentina, S2000DEJ
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      • San Fernando, Argentina, 1646
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      • San Miguel de Tucuman, Argentina, 4000
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  • Austria
      • Bludenz, Austria, 6700
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      • Feldbach, Austria, A-8330
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      • Hallein, Austria, 5400
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      • Linz, Austria, 04020
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  • Belgium
      • Brussels, Belgium, 1070
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      • Erpent, Belgium, 5101
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      • Gilly, Belgium, 6060
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      • Jambes, Belgium, 5100
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      • Liège, Belgium, 4000
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      • Roeselare, Belgium, 8800
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  • Brazil
      • Botucatu, Brazil, 18618-970
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      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90470-340
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      • Porto Alegre, Brazil, 90035074
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      • Santo Andre, Brazil, 09080-110
        • Research Site
      • Sao Bernardo do Campo, Brazil, 09750-420
        • Research Site
      • Sao Paulo, Brazil, 04039-901
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      • Sorocaba, Brazil, 18040-425
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      • São Paulo, Brazil, 01228-200
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      • Uberlandia, Brazil, 38411-186
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      • Vitória, Brazil, 29055-450
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  • Canada
      • Quebec, Canada, G1V 4G5
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      • Quebec, Canada, G2J 0C4
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    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
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      • Windsor, Ontario, Canada, N8X 1T3
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      • Windsor, Ontario, Canada, N8X 5A6
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    • Quebec
      • St Charles Borromee, Quebec, Canada, J6E 2B4
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      • Trois-Rivières, Quebec, Canada, G8T 7A1
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  • Chile
      • Curico, Chile, 3341643
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      • Santiago, Chile, 8380456
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      • Santiago, Chile, 8380453
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      • Talca, Chile, 3465584
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      • Talcahuano, Chile, 4270918
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  • Denmark
      • Aarhus N, Denmark, 8200
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      • Hvidovre, Denmark, 2650
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      • Kolding, Denmark, 6000
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      • København NV, Denmark, 2400
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      • Odense C, Denmark, 5000
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      • Roskilde, Denmark, 4000
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      • Silkeborg, Denmark, 8600
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      • Ålborg, Denmark, 9000
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  • Germany
      • Berlin, Germany, 14059
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      • Berlin, Germany, 10119
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      • Berlin, Germany, 12157
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      • Berlin, Germany, 13187
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      • Cottbus, Germany, 03044
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      • Frankfurt, Germany, 60596
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      • Köln, Germany, 51069
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      • Leipzig, Germany, 04357
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      • Lübeck, Germany, 23552
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      • Rodgau-Dudenhofen, Germany, 63110
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  • Italy
      • Bari, Italy, 70124
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      • Catania, Italy, 95123
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      • Ferrara, Italy, 44121
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      • Legnago, Italy, 37045
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      • Monza, Italy, 20900
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      • Napoli, Italy, 80131
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      • Padova, Italy, 35128
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      • Pavia, Italy, 27100
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      • Riccione, Italy, 47838
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      • Rimini, Italy, 47921
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      • Roma, Italy, 00168
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      • Roma, Italy, 00100
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      • Sassari, Italy, 07100
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  • Mexico
      • Cdmx, Mexico, 6760
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      • Durango, Mexico, 43080
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      • Guadalajara, Mexico, 44130
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      • Guadalajara, Mexico, 44200
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      • Guadalajara, Mexico, 44100
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      • Minatitlán, Mexico, 96730
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      • Monterrey, Mexico, 64460
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      • Sonora, Mexico, 83000
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      • Villahermosa, Mexico, 86035
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  • Norway
      • Arendal, Norway, 4841
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      • Hønefoss, Norway, N-3515
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      • Kråkeroy, Norway, N-1671
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      • Stavanger, Norway, N-4005
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      • Svelvik, Norway, 3060
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      • Trondheim, Norway, 7030
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  • Peru
      • Chancay, Peru, 15131
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      • Cusco, Peru
        • Research Site
      • Lima, Peru, L27
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      • Lima, Peru, LIMA 1
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      • Lima, Peru, LIMA 31
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      • Lima, Peru, 41
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      • Lima, Peru, Lima 32
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      • Lima, Peru, L41
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      • Lima, Peru, L18
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      • Lima, Peru, LIMA 21
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      • Piura, Peru
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  • Puerto Rico
      • Ponce, Puerto Rico, 00717
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      • San Juan, Puerto Rico, 00927
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  • Russian Federation
      • Ekaterinburg, Russian Federation, 620039
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      • Izhevsk, Russian Federation, 426035
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      • Moscow, Russian Federation, 105077
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      • Novosibirsk, Russian Federation, 630008
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      • Novosibirsk, Russian Federation, 630084
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      • Omsk, Russian Federation, 644043
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      • Penza, Russian Federation, 440067
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      • Perm, Russian Federation, 614000
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      • Saint Petersburg, Russian Federation, 196601
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      • Saint-Petersburg, Russian Federation, 197022
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      • StPetersburg, Russian Federation, 191180
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      • Ulyanovsk, Russian Federation, 432009
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  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
      • Cape Town, South Africa, 7764
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      • Cape Town, South Africa, 7570
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      • Cape Town, South Africa, 1730
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      • Durban, South Africa, 4001
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      • Johannesburg, South Africa, 2001
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      • Lenasia Ext8, South Africa, 1820
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      • Mowbray, South Africa, 7700
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      • Parow, South Africa
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      • Pretoria, South Africa, 184
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      • Stanger, South Africa, 4450
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  • Spain
      • Alicante, Spain, 03114
        • Research Site
      • Alzira (Valencia), Spain, 46600
        • Research Site
      • Benalmádena (Málaga), Spain, 29631
        • Research Site
      • Cáceres, Spain, 10003
        • Research Site
      • Jerez de la Frontera, Spain, 11407
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      • Laredo, Spain, 39770
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      • Loja (Granada), Spain, 18300
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      • Malaga, Spain, 29010
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      • Marbella (Málaga), Spain, 29603
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      • Palma de Mallorca, Spain, 07010
        • Research Site
      • Sagunto(Valencia), Spain, 46520
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      • Sant Boi de Llobregat, Spain, 08830
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  • Sweden
      • Lund, Sweden, 221 85
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Malmo, Sweden, 21152
        • Research Site
      • Stockholm, Sweden, 114 46
        • Research Site
      • Uppsala, Sweden, 75237
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Research Site
      • Chertsey, United Kingdom, KT16 0PZ
        • Research Site
      • Chester, United Kingdom, CH2 1UL
        • Research Site
      • Doncaster, United Kingdom, DN2 5LT
        • Research Site
      • Lancaster, United Kingdom, LA1 4RP
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      • Sheffield, United Kingdom, S5 7AU
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      • Wishaw, United Kingdom, ML2 0DP
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  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Sheffield, Alabama, United States, 35660
        • Research Site
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Research Site
    • California
      • Costa Mesa, California, United States, 92627
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Long Beach, California, United States, 90822
        • Research Site
      • Palo Alto, California, United States, 94304
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      • San Diego, California, United States, 92120
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      • San Diego, California, United States, 92103
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      • San Diego, California, United States, 92117
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      • Upland, California, United States, 91786
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      • Yorba Linda, California, United States, 92886
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    • Colorado
      • Boulder, Colorado, United States, 80301
        • Research Site
      • Denver, Colorado, United States, 80246
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    • Connecticut
      • New Haven, Connecticut, United States, 06716
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Research Site
      • Chiefland, Florida, United States, 32626
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Leesburg, Florida, United States, 34748
        • Research Site
      • Lehigh Acres, Florida, United States, 33971
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      • Merritt Island, Florida, United States, 32952
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33173
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      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33145
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Orlando, Florida, United States, 32825
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Tampa, Florida, United States, 33607
        • Research Site
      • Winter Park, Florida, United States, 32789
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    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Research Site
      • Dacula, Georgia, United States, 30019
        • Research Site
      • Decatur, Georgia, United States, 30033
        • Research Site
      • Snellville, Georgia, United States, 30078
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Research Site
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Peoria, Illinois, United States, 61602
        • Research Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Research Site
      • Evansville, Indiana, United States, 47714
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Research Site
      • Topeka, Kansas, United States, 66604
        • Research Site
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Research Site
      • Sunset, Louisiana, United States, 70584
        • Research Site
    • Maine
      • Biddeford, Maine, United States, 04005
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Research Site
      • Kansas City, Missouri, United States, 64128
        • Research Site
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63122
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    • Nebraska
      • Lincoln, Nebraska, United States, 68510
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    • Nevada
      • Reno, Nevada, United States, 89506
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    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Research Site
    • New York
      • Bronx, New York, United States, 10459
        • Research Site
      • Brooklyn, New York, United States, 11215
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Hickory, North Carolina, United States, 28602
        • Research Site
      • Hickory, North Carolina, United States, 28601
        • Research Site
      • Lenoir, North Carolina, United States, 28645
        • Research Site
      • Tabor City, North Carolina, United States, 28463
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Columbus, Ohio, United States, 43213
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      • Columbus, Ohio, United States, 43207
        • Research Site
      • Dayton, Ohio, United States, 45417
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Wooster, Ohio, United States, 44691
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
      • Portland, Oregon, United States, 97220
        • Research Site
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15905
        • Research Site
      • Scottdale, Pennsylvania, United States, 15683
        • Research Site
      • Wyomissing, Pennsylvania, United States, 19610
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    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Research Site
      • East Providence, Rhode Island, United States, 02914
        • Research Site
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Gaffney, South Carolina, United States, 29340
        • Research Site
      • Gaffney, South Carolina, United States, 29341
        • Research Site
      • Lancaster, South Carolina, United States, 29720
        • Research Site
      • Orangeburg, South Carolina, United States, 29118
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      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Seneca, South Carolina, United States, 29678
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      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Research Site
      • Knoxville, Tennessee, United States, 37909
        • Research Site
      • Smyrna, Tennessee, United States, 37167
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Austin, Texas, United States, 78758
        • Research Site
      • Baytown, Texas, United States, 77521
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      • Dallas, Texas, United States, 75234
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      • Houston, Texas, United States, 77030
        • Research Site
      • Kerrville, Texas, United States, 78028
        • Research Site
      • Lewisville, Texas, United States, 75067
        • Research Site
      • Lufkin, Texas, United States, 75904
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      • McKinney, Texas, United States, 75069
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      • McKinney, Texas, United States, 75070
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      • Plano, Texas, United States, 75093
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      • Port Arthur, Texas, United States, 77640
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      • Sherman, Texas, United States, 75092
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      • Spring, Texas, United States, 77379
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      • Waco, Texas, United States, 76712
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    • Utah
      • Salt Lake City, Utah, United States, 94102
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
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    • Washington
      • Everett, Washington, United States, 98208
        • Research Site
      • Renton, Washington, United States, 98055
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Give their signed written informed consent to participate
  2. At least 40 years of age and no older than 80 years of age
  3. COPD patients who are symptomatic
  4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
  5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

  1. Current diagnosis of asthma
  2. COPD due to α1-Antitrypsin Deficiency
  3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
  4. Long-term-oxygen therapy (≥ 15 hours a day).

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
EXPERIMENTAL: BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 320/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
EXPERIMENTAL: BFF MDI (PT009) 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 160/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
EXPERIMENTAL: FF MDI (PT005) 9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: FF MDI (PT005) 9.6 μg
Blinded Treatment
Other Names:
  • Formoterol Fumarate Inhalation

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
Measure Description
Time Frame
Morning Pre-dose Trough FEV1
Time Frame: at Week 12
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
at Week 12

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
Measure Description
Time Frame
Time to First Moderate or Severe COPD Exacerbation
Time Frame: over 52 weeks
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Time Frame: over 12 weeks
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: at Week 12
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
at Week 12

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.
Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (ACTUAL)

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 29, 2016

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.
April 4, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2018

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).
March 30, 2016

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.
March 30, 2016

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.
April 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

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.
September 26, 2019

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.
September 3, 2019

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, 2019

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.
  • PT009003

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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