Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

October 31, 2015

Conditions
Opioid-Induced Constipation
Interventions
DRUG

Linaclotide 145 micrograms

DRUG

Linaclotide 290 micrograms

DRUG

Placebo

Matching placebo

Trial Locations (77)

14221

Forest Investigative Site 059, Williamsville

19056

Forest Investigative Site 067, Levittown

19140

Forest Investigative Site 080, Philadelphia

21742

Forest Investigative Site 048, Hagerstown

24073

Forest Investigative Site 078, Christiansburg

27103

Forest Investigative Site 053, Winston-Salem

27203

Forest Investigative Site 082, Asheboro

27403

Forest Investigative Site 052, Greensboro

27410

Forest Investigative Site 055, Greensboro

27514

Forest Investigative Site 054, Chapel Hill

28036

Forest Investigative Site 088, Davidson

28731

Forest Investigative Site 051, Flat Rock

29406

Forest Investigative Site 070, Charleston

30060

Forest Investigative Site 041, Marietta

30189

Forest Investigative Site 042, Woodstock

32129

Forest Investigative Site 034, Port Orange

32257

Forest Investigative Site 023, Jacksonville

32607

Forest Investigative Site 027, Gainesville

32720

Forest Investigative Site 024, DeLand

32765

Forest Investigative Site 022, Oviedo

32801

Forest Investigative Site 040, Orlando

33185

Forest Investigative Site 028, Miami

33319

Forest Investigative Site 037, Lauderdale Lakes

33331

Forest Investigative Site 032, Weston

33409

Forest Investigative Site 039, West Palm Beach

33426

Forest Investigative Site 035, Boynton Beach

33458

Forest Investigative Site 036, Jupiter

33603

Forest Investigative Site 031, Tampa

33606

Forest Investigative Site 033, Tampa

33613

Forest Investigative Site 030, Tampa

33777

Forest Investigative Site 029, Seminole

34208

Forest Investigative Site 038, Bradenton

36207

Forest Investigative Site 002, Anniston

36535

Forest Investigative Site 001, Foley

42431

Forest Investigative Site 045, Madisonville

43213

Forest Investigative Site 061, Columbus

44060

Forest Investigative Site 060, Mentor

44281

Forest Investigative Site 087, Wadsworth

45219

Forest Investigative Site 062, Cincinnati

47714

Forest Investigative Site 044, Evansville

48047

Forest Investigative Site 050, Chesterfield

48504

Forest Investigative Site 049, Flint

58103

Forest Investigative Site 056, Fargo

60616

Forest Investigative Site 043, Chicago

68114

Forest Investigative Site 058, Omaha

68134

Forest Investigative Site 057, Omaha

70006

Forest Investigative Site 046, Metairie

72217

Forest Investigative Site 003, North Little Rock

73103

Forest Investigative Site 064, Oklahoma City

73120

Forest Investigative Site 063, Oklahoma City

74104

Forest Investigative Site 065, Tulsa

75080

Forest Investigative Site 083, Richardson

78209

Forest Investigative Site 074, San Antonio

78215

Forest Investigative Site 073, San Antonio

78229

Forest Investigative Site 071, San Antonio

80904

Forest Investigative Site 020, Colorado Springs

84088

Forest Investigative Site 076, West Jordan

84341

Forest Investigative Site 075, Logan

Forest Investigative Site 084, Ogden

85029

Forest Investigative Site 007, Phoenix

85710

Forest Investigative Site 008, Tucson

91606

Forest Investigative Site 012, North Hollywood

92108

Forest Investigative Site 013, San Diego

92701

Forest Investigative Site 015, Santa Ana

92708

Forest Investigative Site 014, Fountain Valley

92801

Forest Investigative Site 018, Anaheim

92843

Forest Investigative Site 017, Garden Grove

92868

Forest Investigative Site 011, Orange

93702

Forest Investigative Site 019, Fresno

95648

Forest Investigative Site 009, Lincoln

95670

Forest Investigative Site 010, Gold River

95821

Forest Investigative Site 016, Sacramento

97504

Forest Investigative Site 066, Medford

98007

Forest Investigative Site 079, Bellevue

06010

Forest Investigative Site 021, Bristol

02472

Forest Investigative Site 047, Watertown

02864

Forest Investigative Site 068, Cumberland

Sponsors
All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY