Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139776
First received: August 29, 2005
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.


Condition Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Drug: Celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-Inflammatory Medication for Control Of Their Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Occurrence of First Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days Free From Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days in Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Arthritis Pain Numerical Rating Scale (NRS) [ Time Frame: Period III ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritis [ Time Frame: Period III ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Arthritis at Final Visit [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Total Rescue Medication Taken (Mean) [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days on Rescue Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Days on Flare Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]

Enrollment: 875
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Celecoxib - Continuous use Drug: Celecoxib

24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.

Placebo used as flare medication when directed.

Active Comparator: Celecoxib - Intermittent use Drug: Celecoxib

24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.

Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion Criteria:

  • Subject has had surgery on index joint.
  • Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
  • Subject has active gastrointestinal or cardiovascular disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00139776

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Locations
United States, Alabama
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85051
United States, California
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Anaheim, California, United States, 92801
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Huntington Beach, California, United States, 92646
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Long Beach, California, United States, 90806
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Orange, California, United States, 92868
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Paramount, California, United States, 90723
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Stockton, California, United States, 95204
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Tustin, California, United States, 92780
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Walnut Creek, California, United States, 94598
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Whittier, California, United States, 90601
United States, Colorado
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Wheatridge, Colorado, United States, 80033
United States, Connecticut
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Danbury, Connecticut, United States, 06810
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New Milford, Connecticut, United States, 06776
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Ocala, Florida, United States, 34474
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Palm Harbor, Florida, United States, 34684
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South Miami, Florida, United States, 33143
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Tampa, Florida, United States, 33614-7118
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Zephyrhills, Florida, United States, 33542
United States, Georgia
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Decatur, Georgia, United States, 30033
United States, Illinois
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Springfield, Illinois, United States, 62704
United States, Iowa
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Dubuque, Iowa, United States, 52001-7313
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Dubuque, Iowa, United States, 52002
United States, Kentucky
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Lexington, Kentucky, United States, 40509
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Madisonville, Kentucky, United States, 42431
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Baltimore, Maryland, United States, 21218
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Clinton, Maryland, United States, 20735
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Frederick, Maryland, United States, 21702
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Greenbelt, Maryland, United States, 20770
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Wheaton, Maryland, United States, 20902
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Brockton, Massachusetts, United States, 02301
United States, Missouri
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Jefferson City, Missouri, United States, 65101
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Jefferson City, Missouri, United States, 65109
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Springfield, Missouri, United States, 65807
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89144
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Great Neck, New York, United States, 11021
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Manlius, New York, United States, 13104
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Mineola, New York, United States, 11501
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New York, New York, United States, 10022-1009
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Rochester, New York, United States, 14609
United States, North Carolina
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Winston Salem, North Carolina, United States, 27103-4019
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43210-1228
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Zanesville, Ohio, United States, 43701
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Beaver, Pennsylvania, United States, 15009
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Camp Hill, Pennsylvania, United States, 17011
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Duncansville, Pennsylvania, United States, 16635-0909
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Johnstown, Pennsylvania, United States, 15904
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Philadephia, Pennsylvania, United States, 19152
United States, Tennessee
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Johnson City, Tennessee, United States, 37601
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Knoxville, Tennessee, United States, 37920
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New Tazewell, Tennessee, United States, 37825
United States, Texas
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75231
United States, Virginia
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Arlington, Virginia, United States, 22205
United States, Washington
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Renton, Washington, United States, 98055
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Tacoma, Washington, United States, 98405
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Yakima, Washington, United States, 98902-4876
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Yakima, Washington, United States, 98902
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53209
Belgium
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Ham, Belgium, 3945
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Liege, Belgium, 4000
Brazil
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Porto Alegre, RS, Brazil, 90610-000
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Porto Alegre, RS, Brazil, 90035-903
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Campinas, SP, Brazil, 13073-350
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São Paulo, SP, Brazil, 04027-000
Canada, Alberta
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Calgary, Alberta, Canada, T2S 2S7
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5K 1K3
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
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St. John's, Newfoundland and Labrador, Canada, A1E 2E2
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St. John's, Newfoundland and Labrador, Canada, A1E 2C2
Canada, Ontario
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Corunna, Ontario, Canada, N0N 1G0
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Hamilton, Ontario, Canada, L8M 1K7
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London, Ontario, Canada, N6C 5J1
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Newmarket, Ontario, Canada, L3Y 5G8
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North York, Ontario, Canada, M3M 3E5
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Sarnia, Ontario, Canada, N7T 4X3
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Toronto, Ontario, Canada, M9W 4L6
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Windsor, Ontario, Canada, N8X 5A6
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 5Y9
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Montague, Prince Edward Island, Canada, C0A 1R0
Canada, Quebec
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Mirabel, Quebec, Canada, J7J 2K8
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Montreal, Quebec, Canada, H4N 2W2
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Rimouski, Quebec, Canada, G5L 9A8
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Sherbrooke, Quebec, Canada, J1H 1Z1
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Ste-Foy, Quebec, Canada, G1W 4R4
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
Chile
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Santiago, RM, Chile
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Viña Del Mar, V Region, Chile
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Rancagua, VI Región, Chile
Colombia
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Bogota, Cundinamarca, Colombia
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Barranquila, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
France
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Joue Les Tours, France, 37300
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L'Union, France, 31240
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Poitiers, France, 86000
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Tours, France, 37000
United Kingdom
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Randalstown, Co Antrim, United Kingdom, BT41 3AE
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Newtownabbey, Co.Antrim, United Kingdom, BT37 9QN
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Leslie, Fife, United Kingdom, KY6 3LQ
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Watford, Herts, United Kingdom, WD25 0EA
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Canterbury, Kent, United Kingdom, CT1 3HX
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Wigan, Lancs, United Kingdom, WN6 9EP
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Bradwell Common, Milton Keynes, United Kingdom, MK13 8RN
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Greenisland, Carrickfergus, Northern Ireland, United Kingdom, BT38 8TP
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Barry, Vale of Glamorgan, United Kingdom, CF62 7EB
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Pound Hill, Crawley, West Sussex, United Kingdom, RH10 7DX
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Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
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Midsomer Norton, Wiltshire, United Kingdom, BA3 2UH
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Bangor, United Kingdom, BT19 1PP
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Bath, United Kingdom, BA2 4BY
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Belfast, United Kingdom, BT14 6AR
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Blackpool, United Kingdom, FY4 3AD
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Cardiff, United Kingdom, CF24 2HP
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Cookstown, United Kingdom, BT80 8BG
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Trowbridge, United Kingdom, BA14 9AR
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00139776     History of Changes
Other Study ID Numbers: A3191173
Study First Received: August 29, 2005
Results First Received: February 20, 2009
Last Updated: June 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014