Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Low Back Pain
Interventions
DRUG

Oxycodone/Naloxone controlled-release

Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours

DRUG

Oxycodone HCl controlled-release

Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours

DRUG

Placebo

Placebo tablets to match OXN or OXY taken orally every 12 hours

Trial Locations (194)

10022

Investigational Site, New York

11023

Investigational Site, Great Neck

11516

Investigational Site, Cedarhurst

11758

Investigational Site, North Massapequa

12553

Investigational Site, New Windsor

14221

Investigational Site, Williamsville

15904

Investigational Site, Johnstown

16602

Investigational Site, Altoona

16684

Investigational Site, Tipton

19046

Investigational Site, Jenkintown

19152

Investigational Site, Philadelphia

19460

Investigational Site, Phoenixville

20636

Investigational Site, Hollywood

23220

Investigational Site, Richmond

23235

Investigational Site, Richmond

23454

Investigational Site, Virginia Beach

27103

Investigational Site, Winston-Salem

28621

Investigational Site, Elkin

29303

Investigational Site, Spartanburg

29588

Investigational Site, Myrtle Beach

30060

Investigational Site, Marietta

30097

Investigational Site, Johns Creek

30106

Investigational Site, Austell

30114

Investigational Site, Canton

30513

Investigational Site, Blue Ridge

31069

Investigational Site, Perry

31405

Investigational Site, Savannah

31904

Investigational Site, Columbus

32117

Investigational Site, Daytona Beach

32129

Investigational Site, Port Orange

32216

Investigational Site, Jacksonville

32257

Investigational Site, Jacksonville

32765

Investigational Site, Oviedo

32771

Investigational Site, Sanford

32806

Investigational Site, Orlando

33012

Investigational Site, Hialeah

33013

Investigational Site, Hialeah

33014

Investigational Site, Miami Lakes

33125

Investigational Site, Miami

33126

Investigational Site, Miami

33134

Investigational Site, Coral Gables

33135

Investigational Site, Miami

33143

Investigational Site, Miami

Investigational Site, South Miami

33162

Investigational Site, North Miami Beach

33180

Investigational Site, Aventura

33185

Investigational Site, Miami

33316

Investigational Site, Fort Lauderdale

33317

Investigational Site, Plantation

33321

Investigational Site, Tamarac

33414

Investigational Site, Wellington

33458

Investigational Site, Jupiter

33472

Investigational Site, Boynton Beach

33607

Investigational Site, Tampa

33613

Investigational Site, Tampa

33765

Investigational Site, Clearwater

33781

Investigational Site, Pinellas Park

33782

Investigational Site, Pinellas Park

34110

Investigational Site, Naples

34113

Investigational Site, Naples

34209

Investigational Site, Bradenton

34452

Investigational Site, Inverness

34652

Investigational Site, New Port Richey

34711

Investigational Site, Clermont

35007

Investigational Site, Alabaster

35209

Investigational Site, Homewood

35242

Investigational Site, Birmingham

35801

Investigational Site, Huntsville

36542

Investigational Site, Gulf Shores

36608

Investigational Site, Mobile

37067

Investigational Site, Franklin

37825

Investigational Site, New Tazewell

40504

Investigational Site, Lexington

42431

Investigational Site, Madisonville

43125

Investigational Site, Groveport

43210

Investigational Site, Columbus

43214

Investigational Site, Columbus

43623

Investigational Site, Toledo

44122

Investigational Site, Cleveland

45005

Investigational Site, Franklin

45242

Investigational Site, Cincinnati

45432

Investigational Site, Beavercreek

47714

Investigational Site, Evansville

48085

Investigational Site, Troy

48307

Investigational Site, Rochester

48650

Investigational Site, Pinconning

48706

Investigational Site, Bay City

60657

Investigational Site, Chicago

61701

Investigational Site, Bloomington

63042

Investigational Site, Hazelwood

63128

Investigational Site, St Louis

63141

Investigational Site, St Louis

66160

Investigational Site, Kansas City

67203

Investigational Site, Wichita

70006

Investigational Site, Metairie

70072

Investigational Site, Marrero

70435

Investigational Site, Covington

70809

Investigational Site, Baton Rouge

71901

Investigational Site, Hot Springs

72211

Investigational Site, Little Rock

73119

Investigational Site, Oklahoma City

75075

Investigational Site, Plano

75231

Investigational Site, Dallas

75251

Investigational Site, Dallas

75751

Investigational Site, Athens

76011

Investigational Site, Arlington

76180

Investigational Site, North Richland Hills

77005

Investigational Site, Houston

77024

Investigational Site, Houston

77025

Investigational Site, Houston

77030

Investigational Site, Houston

77057

Investigational Site, Houston

77065

Investigational Site, Houston

77074

Investigational Site, Houston

77098

Investigational Site, Houston

77338

Investigational Site, Humble

77375

Investigational Site, Tomball

77478

Investigational Site, Sugar Land

78229

Investigational Site, San Antonio

78238

Investigational Site, San Antonio

78756

Investigational Site, Austin

80401

Investigational Site, Golden

83642

Investigational Site, Meridian

83702

Investigational Site, Boise

84015

Investigational Site, Clinton

84088

Investigational Site, West Jordan

84102

Investigational Site, Salt Lake City

84107

Investigational Site, Salt Lake City

85018

Investigational Site, Phoenix

85027

Investigational Site, Phoenix

85282

Investigational Site, Tempe

85395

Investigational Site, Goodyear

85704

Investigational Site, Tucson

87106

Investigational Site, Albuquerque

89119

Investigational Site, Las Vegas

90017

Investigational Site, Los Angeles

90025

Investigational Site, Los Angeles

90036

Investigational Site, Los Angeles

90723

Investigational Site, Paramount

90806

Investigational Site, Long Beach

91206

Investigational Site, Glendale

91350

Investigational Site, Santa Clarita

91606

Investigational Site, North Hollywood

91607

Investigational Site, Valley Village

91710

Investigational Site, Chino

91942

Investigational Site, La Mesa

91950

Investigational Site, National City

92056

Investigational Site, Oceanside

92114

Investigational Site, San Diego

92637

Investigational Site, Laguna Hills

92701

Investigational Site, Santa Ana

92801

Investigational Site, Anaheim

92804

Investigational Site, Anaheim

92805

Investigational Site, Anaheim

93720

Investigational Site, Fresno

93726

Investigational Site, Fresno

94806

Investigational Site, Richmond

95032

Investigational Site, Los Gatos

95123

Investigational Site, Catania

95661

Investigational Site, Roseville

95823

Investigational Site, Sacramento

95842

Investigational Site, Sacramento

85395-2511

Investigational Site, Goodyear

06511

Investigational Site, New Haven

06708

Investigational Site, Waterbury

02720

Investigational Site, Fall River

02760

Investigational Site, North Attleboro

08084

Investigational Site, Stratford

08755

Investigational Site, Toms River

08034

Investigational Site, Voorhees Township

02886

Investigational Site, Warwick

656 91

Investigational Site, Brno

500 03

Investigational Site, Hradec Králové

434 64

Investigational Site, Most

775 20

Investigational Site, Olomouc

100 00

Investigational Site, Prague

160 00

Investigational Site, Prague

140 59

Investigational Site, Praha 4 - Krc

516 01

Investigational Site, Rychnov nad Kněžnou

785 01

Investigational Site, Sternberk

566 23

Investigational Site, Vysoké Mýto

760 01

Investigational Site, Zlín

669 02

Investigational Site, Znojmo

43-300

Investigational Site, Bielsko-Biala

85-079

Investigational Site, Bydgoszcz

85-796

Investigational Site, Bydgoszcz

80-286

Investigational Site, Gdansk

80-546

Investigational Site, Gdansk

81-366

Investigational Site, Gdynia

40-084

Investigational Site, Katowice

40-683

Investigational Site, Katowice

20-582

Investigational Site, Lublin

20-718

Investigational Site, Lublin

87-100

Investigational Site, Torun

All Listed Sponsors
lead

Purdue Pharma LP

INDUSTRY

NCT01427270 - Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain | Biotech Hunter | Biotech Hunter