A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

450

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 (149)

10023

Investigational Site, New York

11023

Investigational Site, Great Neck

11415

Investigational Site, Kew Gardens

14221

Investigational Site, Williamsville

14618

Investigational Site, Rochester

15215

Investigational Site, Pittsburgh

16801

Investigational Site, State College

17055

Investigational Site, Mechanicsburg

17356

Investigational Site, Red Lion

19046

Investigational Site, Jenkintown

19056

Investigational Site, Levittown

21208

Investigational Site, Pikesville

23114

Investigational Site, Midlothian

23220

Investigational Site, Richmond

24541

Investigational Site, Danville

27103

Investigational Site, Winston-Salem

27262

Investigational Site, High Point

27710

Investigational Site, Durham

28621

Investigational Site, Elkin

29406

Investigational Site, Charleston

29588

Investigational Site, Myrtle Beach

30078

Investigational Site, Snellville

30106

Investigational Site, Austell

30308

Investigational Site, Atlanta

32117

Investigational Site, Daytona Beach

32132

Investigational Site, Edgewater

32168

Investigational Site, New Smyrna Beach

32216

Investigational Site, Jacksonville

32256

Investigational Site, Jacksonville

32257

Investigational Site, Jacksonville

32626

Investigational Site, Chiefland

32720

Investigational Site, DeLand

32765

Investigational Site, Oviedo

32806

Investigational Site, Orlando

33010

Investigational Site, Hialeah

33012

Investigational Site, Hialeah

33015

Investigational Site, Miami

33125

Investigational Site, Miami

33126

Investigational Site, Miami

33135

Investigational Site, Miami

33136

Investigational Site, Miami

33140

Investigational Site, Miami Beach

33144

Investigational Site, Miami

33145

Investigational Site, Miami

33155

Investigational Site, Miami

33161

Investigational Site, North Miami

33165

Investigational Site, Miami

33180

Investigational Site, Aventura

33185

Investigational Site, Miami

33316

Investigational Site, Fort Lauderdale

33317

Investigational Site, Plantation

33321

Investigational Site, Tamarac

33409

Investigational Site, West Palm Beach

33607

Investigational Site, Tampa

33916

Investigational Site, Fort Myers

34110

Investigational Site, Naples

34113

Investigational Site, Naples

34209

Investigational Site, Bradenton

34452

Investigational Site, Inverness

34677

Investigational Site, Oldsmar

34711

Investigational Site, Clermont

35007

Investigational Site, Alabaster

35213

Investigational Site, Birmingham

35216

Investigational Site, Birmingham

36535

Investigational Site, Foley

36608

Investigational Site, Mobile

38305

Investigational Site, Jackson

41017

Investigational Site, Edgewood

43213

Investigational Site, Columbus

43614

Investigational Site, Toledo

45406

Investigational Site, Dayton

45439

Investigational Site, Moraine

46250

Investigational Site, Indianapolis

46360

Investigational Site, Michigan City

47714

Investigational Site, Evansville

57702

Investigational Site, Rapid City

60616

Investigational Site, Chicago

60622

Investigational Site, Chicago

60657

Investigational Site, Chicago

63031

Investigational Site, Florissant

67203

Investigational Site, Wichita

70119

Investigational Site, New Orleans

70601

Investigational Site, Lake Charles

71201

Investigational Site, Monroe

72120

Investigational Site, Sherwood

72211

Investigational Site, Little Rock

73103

Investigational Site, Oklahoma City

73109

Investigational Site, Oklahoma City

73119

Investigational Site, Oklahoma City

75013

Investigational Site, Allen

75070

Investigational Site, McKinney

75203

Investigational Site, Dallas

75218

Investigational Site, Dallas

75231

Investigational Site, Dallas

75251

Investigational Site, Dallas

76180

Investigational Site, North Richland Hills

77062

Investigational Site, Houston

77065

Investigational Site, Houston

77074

Investigational Site, Houston

77098

Investigational Site, Houston

77375

Investigational Site, Tomball

78731

Investigational Site, Austin

80246

Investigational Site, Denver

80401

Investigational Site, Golden

80907

Investigational Site, Colorado Springs

80909

Investigational Site, Colorado Springs

83704

Investigational Site, Boise

83713

Investigational Site, Boise

84058

Investigational Site, Orem

84102

Investigational Site, Salt Lake City

84124

Investigational Site, Salt Lake City

85020

Investigational Site, Phoenix

85021

Investigational Site, Phoenix

85202

Investigational Site, Mesa

85248

Investigational Site, Sun Lakes

85704

Investigational Site, Tucson

85712

Investigational Site, Tucson

89119

Investigational Site, Las Vegas

90509

Investigational Site, Torrance

90701

Investigational Site, Artesia

90703

Investigational Site, Cerritos

90712

Investigational Site, Lakewood

90717

Investigational Site, Lomita

90723

Investigational Site, Paramount

90806

Investigational Site, Long Beach

91360

Investigational Site, Thousand Oaks

91436

Investigational Site, Encino

91710

Investigational Site, Chino

92020

Investigational Site, El Cajon

92054

Investigational Site, Oceanside

92103

Investigational Site, San Diego

92114

Investigational Site, San Diego

92408

Investigational Site, San Bernardino

92653

Investigational Site, Laguna Hills

92708

Investigational Site, Fountain Valley

92801

Investigational Site, Anaheim

92804

Investigational Site, Anaheim

92843

Investigational Site, Garden Grove

92844

Investigational Site, Garden Grove

92868

Investigational Site, Orange

93720

Investigational Site, Fresno

95648

Investigational Site, Lincoln

95823

Investigational Site, Sacramento

97404

Investigational Site, Eugene

98011

Investigational Site, Bothell

02301

Investigational Site, Brockton

01605

Investigational Site, Worcester

08004

Investigational Site, Atco

02886

Investigational Site, Warwick

All Listed Sponsors
lead

Purdue Pharma LP

INDUSTRY

NCT01427283 - A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain | Biotech Hunter | Biotech Hunter