Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

PHASE4TerminatedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Cancer PainBreakthrough Pain
Interventions
DRUG

Fentanyl Buccal Tablet (FBT)

FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800 mcg). For the open-label treatment and continuation periods, single dose tablets at the effective dose identified during the titration period were used. The maximum dose allowed per breakthrough pain (BTP) episode was 800 mcg. On any single day, participants were not to use FBT for more than 4 BTP episodes.

Trial Locations (123)

133

Investigational Site, Roma

144

Investigational Site, Roma

161

Investigational Site, Roma

9121

Investigational Site, Cagliari

10060

Investigational Site, Candiolo

10126

Investigational Site, Torino

10153

Investigational Site, Torino

10435

Investigational Site, Berlin

11009

Investigational Site, Cadiz

13353

Investigational Site, Berlin

13585

Investigational Site, Berlin

14002

Investigational Site, Córdoba

14033

Investigational Site, Caen

14089

Investigational Site, Berlin

15006

Investigational Site, A Coruña

15009

Investigational Site, A Coruña

15706

Investigational Site, Santiago de Compostela

16128

Investigational Site, Genova

18012

Investigational Site, Granada

18059

Investigational Site, Rostock

20024

Investigational Site, Garbagnate Milanese

20142

Investigational Site, Milan

21502

Investigational Site, Geesthacht

25123

Investigational Site, Brescia

28006

Investigational Site, Madrid

28035

Investigational Site, Madrid

28046

Investigational Site, Madrid

28195

Investigational Site, Lleida

29100

Investigational Site, Piacenza

30625

Investigational Site, Hanover

31008

Investigational Site, Pamplona

31059

Investigational Site, Toulouse

31135

Investigational Site, Hildesheim

33075

Investigational Site, Bordeaux

33081

Investigational Site, Aviano

33175

Investigational Site, Bad Lippspringe

34117

Investigational Site, Kassel

34298

Investigational Site, Montpellier

35753

Investigational Site, Greifenstein

37007

Investigational Site, Salamanca

37024

Investigational Site, Verona

38043

Investigational Site, Grenoble

38320

Investigational Site, San Cristóbal de La Laguna

39008

Investigational Site, Santander

41009

Investigational Site, Seville

41013

Investigational Site, Seville

41100

Investigational Site, Modena

43100

Investigational Site, Tychy

43300

Investigational Site, Bielsko-Biala

44101

Investigational Site, Gliwice

44534

Investigational Site, Lünen

44623

Investigational Site, Herne

44805

Investigational Site, Saint-Herblain

45032

Investigational Site, Orléans

46014

Investigational Site, Valencia

46015

Investigational Site, Valencia

47055

Investigational Site, Duisburg

47166

Investigational Site, Duisburg

48013

Investigational Site, Bilbao

48022

Investigational Site, Lugo

50100

Investigational Site, Florence

52146

Investigational Site, Würselen

53111

Investigational Site, Bonn

53413

Investigational Site, Wroclaw

53604

Investigational Site, Bad Honnef

55131

Investigational Site, Mainz

56100

Investigational Site, Pisa

58033

Investigational Site, Nevers

58107

Investigational Site, Lorient

60245

Investigational Site, Poznan

61866

Investigational Site, Poznan

62041

Investigational Site, Puszczykowo

64100

Investigational Site, Bayonne

65000

Investigational Site, Tarbes

67100

Investigational Site, L’Aquila

69495

Investigational Site, Pierre-Bénite

70120

Investigational Site, Bari

71730

Investigational Site, Szczecin

71740

Investigational Site, Szczecin

72018

Investigational Site, Le Mans

75010

Investigational Site, Paris

75013

Investigational Site, Paris

75730

Investigational Site, Paris

76031

Investigational Site, Rouen

78157

Investigational Site, Le Chesnay

79108

Investigational Site, Freiburg im Breisgau

80131

Investigational Site, Napoli

80208

Investigational Site, Gdansk

80637

Investigational Site, Munich

80952

Investigational Site, Gdansk

81100

Investigational Site, Caserta

81377

Investigational Site, Munich

82300

Investigational Site, Elblag

85796

Investigational Site, Bydgoszcz

86021

Investigational Site, Poitiers

87100

Investigational Site, Cosenza

87800

Investigational Site, Włocławek

90146

Investigational Site, Palermo

90251

Investigational Site, Lodz

92110

Investigational Site, Clichy

92637

Investigational Site, Weiden

94275

Investigational Site, Le Kremlin-Bicêtre

94800

Investigational Site, Villejuif

99084

Investigational Site, Erfurt

99974

Investigational Site, Mülhausen

04564

Investigational Site, Böhlen

01307

Investigational Site, Dresden

07747

Investigational Site, Jena

04107

Investigational Site, Leipzig

02999

Investigational Site, Lohsa

01844

Investigational Site, Neustadt

Unknown

Investigational Site, Dublin

02781

Investigational Site, Warsaw

08025

Investigational Site, Barcelona

08907

Investigational Site, Barcelona

07012

Investigational Site, Palma de Mallorca

BA15 2LG

Investigational Site, Bath

DG1 4AP

Investigational Site, Dumfries

SW3 6JJ

Investigational Site, London

NG5 1PB

Investigational Site, Nottingham

PL68DH

Investigational Site, Plymouth

KT10 8NA

Investigational Site, Surrey

SM2 5PT

Investigational Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT00842829 - Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients | Biotech Hunter | Biotech Hunter