Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

PHASE3TerminatedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Ulcerative Colitis
Interventions
DRUG

Asacol 400 mg

17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM

DRUG

Asacol 400 mg

17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM

Trial Locations (51)

11040

Research Site, New Hyde Park

14222

Research Site, Buffalo

25701

Research Site, Huntington

32601

Research Site, Gainesville

33155

Research Site, Miami

35233

Research Site, Birmingham

37232

Research Site, Nashville

39202

Research Site, Jackson

40202

Research Site, Louisville

48075

Research Site, Southfield

60068

Research Site, Park Ridge

64108

Research Site, Kansas City

76104

Research Site, Fort Worth

78229

Research Site, San Antonio

85016

Research Site, Phoenix

89109

Research Site, Las Vegas

92123

Research Site, San Diego

92354

Research Site, Loma Linda

94118

Research Site, San Francisco

94143

Research Site, San Francisco

103001

Research Site, Moscow

105077

Research Site, Moscow

117963

Research Site, Moscow

119021

Research Site, Moscow

127412

Research Site, Moscow

214019

Research Site, Smolensk

420138

Research Site, Kazan'

603950

Research Site, Nizhny Novgorod

630091

Research Site, Novosibirsk

04102

Research Site, Portland

02114

Research Site, Boston

01655

Research Site, Worcester

08330

Research Site, Mays Landing

02903

Research Site, Providence

T6G 2J3

Research Site, Edmonton

B3K 6R8

Research Site, Halifax

L8N 3Z5

Research Site, Hamilton

N6A 5W9

Research Site, London

K1H 8L1

Research Site, Ottawa

Unknown

Research Site, Rijeka

Research Site, Zagreb

15-274

Research Site, Bialystok

85-094

Research Site, Bydgoszcz

40-752

Research Site, Katowice

30-663

Research Site, Krakow

91-738

Research Site, Lodz

04-730

Research Site, Warsaw

50-369

Research Site, Wroclaw

00 17 43

Research Site, Bucharest

04 14 51

Research Site, Bucharest

70 03 09

Research Site, Iași

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT01004185 - Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | Biotech Hunter | Biotech Hunter