Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Ulcerative Colitis
Interventions
DRUG

Asacol 400 mg

"High dose:~17-\<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-\<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-\<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM"

DRUG

Asacol 400 mg

"Low dose:~17-\<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-\<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-\<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM"

Trial Locations (42)

10000

Research Site, Zagreb

11040

Research Facility, New Hyde Park

14222

Research Facility, Buffalo

20010

Research Facility, Washington D.C.

23507

Research Facility, Norfolk

25701

Research Facility, Huntington

32610

Research Facility, Gainesville

35233

Research Facility, Birmingham

37404

Research Facility, Chattanooga

37916

Research Facility, Knoxville

40202

Research Facility, Louisville

44514

Research Facility, Youngstown

51000

Research Site, Rijeka

60068

Research Facility, Park Ridge

64108

Research Facility, Kansas City

68015

Research Facility, Omaha

76104

Research Facility, Fort Worth

77030

Research Facility, Houston

78229

Research Facility, San Antonio

85016

Research Facility, Phoenix

92123

Research Facility, San Diego

92354

Research Facility, Loma Linda

94118

Research Facility, San Francisco

94143

Research Facility, San Francisco

700309

Research Site, Iași

02114

Research Facility, Boston

01655

Research Facility, Worcester

08330

Research Facility, Mays Landing

97239-3098

Research Facility, Portland

B3K 6R8

Research Facility, Halifax

L8N 3Z5

Research Facility, Hamilton

N6A 5W9

Research Facility, London

K1H 8L1

Research Facility, Ottawa

H3T 1C5

Research Facility, Montreal

15-274

Research Site, Bialystok

85-094

Research Site, Bydgoszcz

30-663

Research Site, Krakow

91-738

Research Site, Lodz

04-730

Research Site, Warsazawa

50-369

Research Site, Wroclaw

011743

Research Site, Bucharest

041451

Research Site, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT00713310 - Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter