Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

PHASE3CompletedINTERVENTIONAL
Enrollment

487

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

August 31, 2013

Conditions
Chronic ConstipationConstipation
Interventions
DRUG

Linaclotide 290 micrograms

oral capsule, taken once daily each morning at least 30 minutes before breakfast

DRUG

Linaclotide 145 micrograms

oral capsule, taken once daily each morning at least 30 minutes before breakfast

DRUG

Matching placebo

oral capsule, taken once daily each morning at least 30 minutes before breakfast

Trial Locations (151)

11021

Forest Investigative Site 017, Great Neck

11206

Forest Investigative Site 044, Brooklyn

15206

Forest Investigative Site 001, Pittsburgh

19056

Forest Investigative Site 081, Levittown

19606

Forest Investigative Site 110, Reading

20815

Forest Investigative Site 008, Chevy Chase

21215

Forest Investigative Site 062, Baltimore

21286

Forest Investigative Site 024, Towson

21742

Forest Investigative Site 014, Hagerstown

22911

Forest Investigative Site 053, Charlottesville

23294

Forest Investigative Site 038, Richmond

23320

Forest Investigative Site 108, Chesapeake

Forest Investigative Site 136, Chesapeake

23502

Forest Investigative Site 013, Norfolk

23606

Forest Investigative Site 069, Newport News

24073

Forest Investigative Site 148, Christiansburg

24502

Forest Investigative Site 072, Lynchburg

27103

Forest Investigative Site 074, Winston-Salem

27203

Forest Investigative Site 142, Asheboro

27262

Forest Investigative Site 139, High Point

27403

Forest Investigative Site 031, Greensboro

27408

Forest Investigative Site 029, Greensboro

Forest Investigative Site 078, Greensboro

27612

Forest Investigative Site 027, Raleigh

28036

Forest Investigative Site 140, Davidson

28075

Forest Investigative Site 084, Harrisburg

28304

Forest Investigative Site 039, Fayetteville

28401

Forest Investigative Site 089, Wilmington

28601

Forest Investigative Site 073, Hickory

28602

Forest Investigative Site 050, Hickory

28607

Forest Investigative Site 075, Boone

28625

Forest Investigative Site 119, Statesville

28801

Forest Investigative Site 094, Asheville

29650

Forest Investigative Site 116, Greer

29681

Forest Investigative Site 046, Simpsonville

30060

Forest Investigative Site 021, Marietta

30067

Forest Investigative Site 011, Marietta

30189

Forest Investigative Site 023, Woodstock

30281

Forest Investigative Site 037, Stockbridge

30328

Forest Investigative Site 109, Sandy Springs

32129

Forest Investigative Site 132, Port Orange

32168

Forest Investigative Site 130, New Smyrna Beach

32205

Forest Investigative Site 114, Jacksonville

32720

Forest Investigative Site 131, DeLand

32765

Forest Investigative Site 150, Oviedo

32806

Forest Investigative Site 083, Orlando

33134

Forest Investigative Site 133, Coral Gables

33143

Forest Investigative Site 003, Miami

33183

Forest Investigative Site 002, Miami

33319

Forest Investigative Site 097, Lauderdale Lakes

33426

Forest Investigative Site 091, Boynton Beach

33458

Forest Investigative Site 004, Jupiter

33542

Forest Investigative Site 115, Zephyrhills

33606

Forest Investigative Site 064, Tampa

33709

Forest Investigative Site 087, St. Petersburg

33777

Forest Investigative Site 127, Seminole

33916

Forest Investigative Site 051, Fort Myers

34208

Forest Investigative Site 047, Bradenton

34452

Forest Investigative Site 137, Inverness

34471

Forest Investigative Site 040, Ocala

34601

Forest Investigative Site 042, Brooksville

34741

Forest Investigative Site 016, Kissimmee

37421

Forest Investigative Site 129, Chattanooga

37660

Forest Investigative Site 138, Kingsport

39202

Forest Investigative Site 141, Jackson

40509

Forest Investigative Site 128, Lexington

42431

Forest Investigative Site 134, Madisonville

43215

Forest Investigative Site 026, Columbus

44060

Forest Investigative Site 085, Mentor

44122

Forest Investigative Site 056, Cleveland

44281

Forest Investigative Site 068, Wadsworth

45242

Forest Investigative Site 025, Cincinnati

45249

Forest Investigative Site 120, Cincinnati

45415

Forest Investigative Site 098, Dayton

45432

Forest Investigative Site 090, Dayton

46011

Forest Investigative Site 107, Anderson

48047

Forest Investigative Site 070, Chesterfield

49684

Forest Investigative Site 145, Traverse City

50325

Forest Investigative Site 117, Clive

Forest Investigative Site 146, Clive

52242

Forest Investigative Site 055, Iowa City

52807

Forest Investigative Site 143, Davenport

53215

Forest Investigative Site 096, Milwaukee

54601

Forest Investigative Site 082, La Crosse

57049

Forest Investigative Site 092, Dakota Dunes

61107

Forest Investigative Site 043, Rockford

61602

Forest Investigative Site 122, Peoria

66215

Forest Investigative Site 112, Overland Park

67114

Forest Investigative Site 028, Newton

67205

Forest Investigative Site 034, Wichita

67207

Forest Investigative Site 032, Wichita

68025

Forest Investigative Site 077, Fremont

68134

Forest Investigative Site 048, Omaha

70006

Forest Investigative Site 124, Metairie

70809

Forest Investigative Site 121, Baton Rouge

71101

Forest Investigative Site 058, Shreveport

71103

Forest Investigative Site 099, Shreveport

71201

Forest Investigative Site 101, Monroe

72117

Forest Investigative Site 135, North Little Rock

73104

Forest Investigative Site 118, Oklahoma City

75231

Forest Investigative Site 035, Dallas

75234

Forest Investigative Site 005, Dallas

76135

Forest Investigative Site 111, Fort Worth

77034

Forest Investigative Site 100, Houston

77450

Forest Investigative Site 067, Katy

77479

Forest Investigative Site 065, Sugarland

77505

Forest Investigative Site 049, Pasadena

78209

Forest Investigative Site 030, San Antonio

78229

Forest Investigative Site 076, San Antonio

78756

Forest Investigative Site 125, Austin

80304

Forest Investigative Site 012, Boulder

80501

Forest Investigative Site 060, Longmont

80904

Forest Investigative Site 041, Colorado Springs

80907

Forest Investigative Site 045, Colorado Springs

83404

Forest Investigative Site 015, Idaho Falls

84094

Forest Investigative Site 113, Sandy City

84107

Forest Investigative Site 105, Salt Lake City

84405

Forest Investigative Site 019, Ogden

85018

Forest Investigative Site 018, Phoenix

85020

Forest Investigative Site 061, Phoenix

85224

Forest Investigative Site 020, Chandler

Forest Investigative Site 102, Chandler

85251

Forest Investigative Site 022, Scottsdale

85308

Forest Investigative Site 149, Glendale

85395

Forest Investigative Site 126, Goodyear

85704

Forest Investigative Site 079, Tucson

85712

Forest Investigative Site 071, Tucson

87106

Forest Investigative Site 063, Albuquerque

87108

Forest Investigative Site 093, Albuquerque

89014

Forest Investigative Site 052, Henderson

89121

Forest Investigative Site 080, Las Vegas

90404

Forest Investigative Site 151, Santa Monica

91345

Forest Investigative Site 066, Mission Hills

91361

Forest Investigative Site 010, Westlake Village

92108

Forest Investigative Site 009, San Diego

92653

Forest Investigative Site 104, Laguna Hills

92801

Forest Investigative Site 106, Anaheim

94070

Forest Investigative Site 095, San Carlos

99208

Forest Investigative Site 103, Spokane

06010

Forest Investigative Site 007, Bristol

06708

Forest Investigative Site 153, Waterbury

02135

Forest Investigative Site 006, Boston

07012

Forest Investigative Site 036, Clifton

08053

Forest Investigative Site 088, Marlton

08360

Forest Investigative Site 033, Vineland

27599-7080

Forest Investigative Site 123, Chapel Hill

P3E 1H5

Forest Investigative Site 054, Greater Sudbury

N7T 4X3

Forest Investigative Site 059, Sarnia

M4S 1Y2

Forest Investigative Site 086, Toronto

M9W 4L6

Forest Investigative Site 147, Toronto

L4L 4Y7

Forest Investigative Site 152, Vaughan

Sponsors
All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY