Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

TerminatedOBSERVATIONAL
Enrollment

17

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 8, 2020

Study Completion Date

April 8, 2020

Conditions
Fibrosing Colonopathy
Interventions
BIOLOGICAL

ULTRESA

pancreatic enzyme replacement therapy

BIOLOGICAL

PANCREAZE

pancreatic enzyme replacement therapy

BIOLOGICAL

CREON

pancreatic enzyme replacement therapy

BIOLOGICAL

ZENPEP

pancreatic enzyme replacement therapy

BIOLOGICAL

other non-sponsor pancreatic enzyme replacement therapy

pancreatic enzyme replacement therapy

BIOLOGICAL

PERTZYE

pancreatic enzyme replacement therapy

OTHER

No pancreatic enzyme replacement therapy

Cystic fibrosis patients in the cystic fibrosis registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)

Trial Locations (123)

10003

Mount Sinai Beth Israel /ID# 76773, New York

10595

New York Medical College /ID# 78956, Valhalla

11040

North Shore University Hospital /ID# 76779, New Hyde Park

12208

Albany Medical College /ID# 76774, Albany

13210

SUNY Upstate Medical University - Downtown /ID# 78912, Syracuse

14222

Cystic Fibrosis Therapeutics /ID# 78941, Buffalo

14642

Univ Rochester Med Ctr /ID# 92713, Rochester

17033

Penn State Child Hosp.Hersh,PA /ID# 79398, Hershey

17822

Geisinger Medical Center /ID# 79233, Danville

19104

Children's Hosp Philadelphia /ID# 79280, Philadelphia

19129

Drexel Univ College of Med /ID# 76777, Philadelphia

19134

St. Christopher's Hospital /ID# 78908, Philadelphia

19803

Nemours/Alfred duPont Hospital for Children /ID# 78945, Wilmington

20010

Children's National Medical Center /ID# 79373, Washington D.C.

21287

Johns Hopkins University /ID# 78893, Baltimore

22908

University of Virginia /ID# 78942, Charlottesville

23298

Children's Hospital of Richmon /ID# 78955, Richmond

23507

Child Hosp of the King's Dtr's /ID# 79293, Norfolk

26506

West Virginia Univ School Med /ID# 78953, Morgantown

29425

Medical University of South Carolina /ID# 79262, Charleston

30322

Emory University Hospital /ID# 79394, Atlanta

30912

Georgia Regents University /ID# 79395, Augusta

32207

Nemour Child Clin FL, US /ID# 78898, Jacksonville

32610

University of Florida - Archer /ID# 76790, Gainesville

University of Florida - Archer /ID# 78928, Gainesville

32701

Central FL Pulmonary Altamonte /ID# 76776, Altamonte Springs

32801

Nemours Children's Clinic /ID# 78917, Orlando

32806

Arnold Palmer Hosp Children /ID# 96075, Orlando

33136

University of Miami, Miller School of Medicine /ID# 78927, Miami

33701

All Children's Hospital /ID# 79264, St. Petersburg

35233

Children's Hospital of Alabama /ID# 78920, Birmingham

38103

LeBonheur Children's Med Ctr /ID# 78938, Memphis

40202

University of Louisville /ID# 78926, Louisville

40506

Kentucky Clinic /ID# 78922, Lexington

43205

Nationwide Childrens Hospital /ID# 78897, Columbus

43606

ProMedica Toledo Hospital /ID# 78913, Toledo

44106

Case Western Reserve Univ /ID# 78904, Cleveland

44308

Akron Childrens Hospital /ID# 79263, Akron

45229

Cincinnati Children's Hospital /ID# 79375, Cincinnati

45404

The Childrens Medical Center /ID# 78915, Dayton

46202

Indiana University /ID# 121395, Indianapolis

Indiana University /ID# 78903, Indianapolis

46804

Lutheran Hospital of Indiana /ID# 79238, Fort Wayne

48109

University of Michigan Hospitals /ID# 99035, Ann Arbor

48201

Children's Hospital of MI /ID# 79278, Detroit

48824

Michigan State University /ID# 78950, East Lansing

49503

Helen DeVos Childrens Hospital /ID# 79397, Grand Rapids

52242

University of Iowa Hospitals and Clinics /ID# 78921, Iowa City

53226

Children's Hospital Wisconsin - Milwaukee Campus /ID# 79294, Milwaukee

58504

Mid Dakota Clinic, PC /ID# 78958, Bismarck

60068

Advocate Lutheran Gen Children /ID# 76781, Park Ridge

60153

Loyola University Medical Ctr /ID# 76780, Maywood

60611

Duplicate_Childrens Hospital of Chicago /ID# 79296, Chicago

61603

OSF Saint Francis Medical Ctr /ID# 78905, Peoria

63104

Cardinal Glennon Children's Ho /ID# 79275, St Louis

63110

Children's Hospital St Louis /ID# 78910, St Louis

64108

The Children's Mercy Hospital /ID# 78948, Kansas City

65212

University of Missouri /ID# 109755, Columbia

67214

Via Christi Specialty Clinics /ID# 78946, Wichita

68198

Univ Nebraska Med Ctr /ID# 78932, Omaha

70112

Tulane Univ /ID# 78916, New Orleans

71130

Louisiana State Univ HSC /ID# 78943, Shreveport

72202

Arkansas Children's Hospital /ID# 79265, Little Rock

72205

University of Arkansas for Medical Sciences /ID# 76785, Little Rock

73104

Univ Oklahoma HSC /ID# 79279, Oklahoma City

75708

The Univ Texas HSC at Tyler /ID# 79261, Tyler

76104

Cook Children's Med. Center /ID# 78949, Fort Worth

78229

Univ Texas HSC San Antonio /ID# 79374, San Antonio

78723

Specially for Children /ID# 79213, Austin

80045

Univ of Colorado Cancer Center /ID# 79277, Aurora

80206

National Jewish Health /ID# 76784, Denver

83702

St Luke's Cystic Fibrosis Center of Idaho /ID# 79259, Boise

90027

Kaiser Permanente Regional Met /ID# 79235, Los Angeles

90033

Usc /Id# 76793, Los Angeles

90806

Miller Childrens Hospital /ID# 78896, Long Beach

92093

Ucsd /Id# 105039, La Jolla

92354

Loma Linda University /ID# 79237, Loma Linda

94115

California Pacific Medical Ctr /ID# 76775, San Francisco

94305

Stanford University /ID# 95156, Stanford

94609

Children's Hosp and Res Ctr /ID# 79295, Oakland

94611

Kaiser Permanente /ID# 78899, Oakland

95817

UC Davis Comprehensive Cancer Center - Main /ID# 118935, Sacramento

97227

Kaiser Permanente, NW /ID# 79236, Portland

97239

Oregon Health and Science University /ID# 78900, Portland

98105

Seattle Children's Hospital /ID# 78902, Seattle

99508

Alaska Medical Center /ID# 79256, Anchorage

85016-7710

Phoenix Children's Hospital /ID# 78906, Phoenix

85719-1478

University of Arizona Cancer Center - North Campus /ID# 78939, Tucson

94143-2204

Univ California, San Francisco /ID# 78925, San Francisco

06106

CT Childrens Medical Ctr, US /ID# 78923, Hartford

06510

Yale University /ID# 78940, New Haven

33021-5402

Joe DiMaggio Children's Hospital at Memorial /ID# 79234, Hollywood

30342-1605

Children's Healthcare of Atlanta - Ferry Rd /ID# 116275, Atlanta

60637-1443

University of Chicago /ID# 78924, Chicago

66160-8500

University of Kansas Health Sy /ID# 78929, Kansas City

04102

MMP Women's Health /ID# 78894, Portland

02111

Tufts-New England Medical Ctr /ID# 79254, Boston

02114

Massachusetts General Hospital /ID# 78895, Boston

02115

Boston Childrens Hospital /ID# 79276, Boston

01199

Baystate Medical Center /ID# 103437, Springfield

01655

UMass Memorial Medical Center /ID# 78954, Worcester

55455-0356

University of Minnesota /ID# 76791, Minneapolis

39216-4643

Univ of Mississippi Med Ctr,US /ID# 78934, Jackson

03756

Dartmouth-Hitchcock Medical Center /ID# 78957, Lebanon

07039

St. Barnabas Medical Center /ID# 79258, Livingston

07740

Monmouth Medical Center /ID# 78901, Long Branch

07960

Goryeb Chidlren's Hospital /ID# 76782, Morristown

08901

Rutgers Robert Wood Johnson /ID# 119978, New Brunswick

10032-3725

Columbia Univ Medical Center /ID# 79376, New York

27514-4220

Univ NC Chapel Hill /ID# 78937, Chapel Hill

27710-3000

Duke University Medical Center /ID# 79393, Durham

45267-0585

University of Cincinnati /ID# 76789, Cincinnati

15213-2583

Child Hosp of Pittsburgh,PA /ID# 79281, Pittsburgh

02903

Rhode Island Hospital /ID# 79274, Providence

57104-8805

Sanford Research/USD /ID# 78909, Sioux Falls

37232-0011

Vanderbilt Univ Med Ctr /ID# 78947, Nashville

75390-7208

UT Southwestern Medical Center /ID# 78914, Dallas

77030-3411

Baylor College of Medicine /ID# 79273, Houston

84112-5500

University of Utah /ID# 76794, Salt Lake City

05401-1473

University of Vermont Medical Center /ID# 78933, Burlington

99204-2336

Arthritis Northwest, PLLC /ID# 79257, Spokane

53792-0001

Univ of Wisconsin Hosp/Clinics /ID# 78944, Madison

53226-3522

Froedtert & the Medical College of Wisconsin /ID# 76778, Milwaukee

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cystic Fibrosis Foundation

OTHER

collaborator

Digestive Care, Inc.

INDUSTRY

collaborator

Nestle Health Science

INDUSTRY

collaborator

VIVUS LLC

INDUSTRY

lead

AbbVie

INDUSTRY