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A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00350415
Collaborator
(none)
772
Enrollment
135
Locations
2
Arms
11
Duration (Months)
5.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
772 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Asacol 2.4 g/day (400 mg tablet)

Drug: Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Active Comparator: 2

Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks

Drug: Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6. [Week 6]

Secondary Outcome Measures

  1. Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3. [week 3 and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.

  • Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

  • Patients with isolated proctitis

  • Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Facility Alabaster Alabama United States 35007
2 Research Facility Birmingham Alabama United States 35209
3 Research Facility Tucson Arizona United States 85712
4 Research Facility Fayetteville Arkansas United States 72703
5 Research Facility Little Rock Arkansas United States 72205
6 Research Facility Anaheim California United States 92801
7 Research Facility Burbank California United States 91505
8 Research Facility Encinitas California United States 93024
9 Research Facility Los Angeles California United States 90067
10 Research Facility Los Angeles California United States 90274
11 Research Facility Mission Hills California United States 91345
12 Research Facility Orange California United States 92868
13 Research Facility Pasadena California United States 91105
14 Research Facility Roseville California United States 95661
15 Research Facility Sacramento California United States 95825
16 Research Facility San Carlos California United States 94070
17 Research Facility San Francisco California United States 94115
18 Research Facility Lakewood Colorado United States 80215
19 Research Facility Littleton Colorado United States 80120
20 Research Facility Hamden Connecticut United States 06518-3691
21 Research Facility Deland Florida United States 32720
22 Research Facility Harbor Florida United States 34684
23 Research Facility Hollywood Florida United States 33021
24 Research Facility Jacksonville Florida United States 32256
25 Research Facility Panama City Florida United States 33405
26 Research Facility Zephyrhills Florida United States 33542
27 Research Facility Atlanta Georgia United States 30033
28 Research Facility Savannah Georgia United States 31405
29 Research Facility Arlington Heights Illinois United States 60005
30 Research Facility Chicago Illinois United States 60637
31 Research Facility Topeka Kansas United States 60606
32 Research Facility Louisville Kentucky United States 40292
33 Research Facility Baton Rouge Louisiana United States 70809
34 Research Facility Shreveport Louisiana United States 71103
35 Research Facility Baltimore Maryland United States 21215
36 Research Facility Chevy Chase Maryland United States 20815
37 Research Facility Reisterstown Maryland United States 21136
38 Research Facility Boston Massachusetts United States 02115
39 Research Facility Columbia Michigan United States 65212
40 Research Facility Minneapolis Minnesota United States 55455
41 Research Facility Rochester Minnesota United States 55905
42 Research Facility Tupelo Mississippi United States 38801
43 Research Facility Kansas City Missouri United States 64131
44 Research Facility St. Louis Missouri United States 63128
45 Research Facility Omaha Nebraska United States 68131
46 Research Facility Scottsbluff Nebraska United States 69361
47 Research Facility Egg Harbor Township New Jersey United States 08234
48 Research Facility Binghamton New York United States 13903
49 Research Facility Garden City New York United States 11530
50 Research Facility Great Neck New York United States 11021
51 Research Facility Huntington New York United States 11743
52 Research Facility New York New York United States 10021
53 Research Facility Rochester New York United States 14642
54 Research Facility Troy New York United States 12180
55 Research Facility Charlotte North Carolina United States 28262
56 Research Facility Wilmington North Carolina United States 28401
57 Research Facility Bismarck North Dakota United States 58501-1640
58 Research Facility Fargo North Dakota United States 58104
59 Research Facility Akron Ohio United States 44302
60 Research Facility Cincinnati Ohio United States 45242
61 Research Facility Dayton Ohio United States 45440
62 Research Facility Warren Ohio United States 44484
63 Research Facility Portland Oregon United States 97220
64 Research Facility Beaver Falls Pennsylvania United States 15010
65 Research Facility Philadelphia Pennsylvania United States 19107
66 Research Facility York Pennsylvania United States 17403
67 Research Facility Columbia South Carolina United States 29203
68 Research Facility Kingsport Tennessee United States 37660
69 Research Facility Memphis Tennessee United States 38120
70 Research Facility Nashville Tennessee United States 37232
71 Research Facility Austin Texas United States 78743
72 Research Facility San Antonio Texas United States 78205
73 Research Facility Murray Utah United States 84107
74 Research Facility Ogden Utah United States 84405
75 Research Facility Burlington Vermont United States 05401
76 Research Facility Chesapeake Virginia United States 23320
77 Research Facility Redmond Washington United States 98052
78 Research Facility Milwaukee Wisconsin United States 53215
79 Research Facility Gornel Gormel Belarus
80 Research Facility Grodno Belarus 230017
81 Research Facility Minsk Belarus 220013
82 Research Facility Vitebsk Belarus 210037
83 Research Facility Edmonton Alberta Canada T6G 2X8
84 Research Facility Abbotsford British Columbia Canada V2S 3N5
85 Research Facility Vancouver British Columbia Canada V5Z 112
86 Research Facility Guelph Ontario Canada N1H 3R3
87 Research Facility Hamilton Ontario Canada L8N 3Z5
88 Research Facility London Ontario Canada N6A 5K8
89 Research Facility Ottawa Ontario Canada K1H 8L6
90 Research Facility Toronto Ontario Canada M3N 2V7
91 Research Facility Levis Quebec Canada G6V 3Z1
92 Research Facility Longheuil Quebec Canada J4N 1E1
93 Research Facility Montreal Quebec Canada H31 1E2
94 Research Facility Quebec City Quebec Canada G1R 2J6
95 Research Facility Rimouski Quebec Canada G5L 5T1
96 Research Facility Saskatoon Saskatchewan Canada S7K 1N4
97 Research Facility Quebec Canada G1L 3L5
98 Research Facility Rijeka Croatia 51000
99 Research Facility Zagreb Croatia 10000
100 Research Facility Kralove Czech Republic 500 12
101 Research Facility Pavlov Czech Republic
102 Research Facility Praha 2 Czech Republic 120 00
103 Research Facility Strakonice Czech Republic 3886 29
104 Research Facility Usti nad Labem Czech Republic 401 13
105 Research Facility Tallinn Estonia 10138
106 Research Facility Tartu Estonia 51014
107 Research Facility Argenti Dome ter Hungary 1-3
108 Research Facility Budapest Hungary
109 Research Facility Nagyerdei krt Hungary 98
110 Research Facility Riga Latvia LV-1002
111 Research Facility Santariskiu Vilnius Lithuania LT-08661
112 Research Facility Kaunas Lithuania LT-50009
113 Research FacilityPanevezys Panevezys Lithuania LT-35144
114 Research Facility Bydgoszcz Poland 85-681
115 Research Facility Czestochowa Poland 42-200
116 Research Facility Krakow Poland 31-501
117 Research Facility Lodz Poland 90-153
118 Research Facility Pruszkow Poland 05-800
119 Research Facility Sopot Poland 81-756
120 Research Facility Warszawa Poland 02-57
121 Research Facility Wtoctawek Poland 87-800
122 Research Facility San Juan Puerto Rico 5067
123 Research Facility Bucuresti 1 Bucuresti Romania 010825
124 Research Facility Cluj-napoca Romania 400162
125 Research Facility Iasi Romania 700111
126 Research Facility Moscow Mowcow Russian Federation 129110
127 Research Facility Nizhny Novgorod Russian Federation 603126
128 Research Facility St. Petersburg Russian Federation 196247
129 Research Facility Beograd Serbia 11080
130 Research Facility Novi Sad Serbia 21000
131 Research Facility Zabolotnogo Odesa Ukraine 65025
132 Research Facility Kharkiv Ukraine 61037
133 Research Facility Kyiv Ukraine 04053
134 Research Facility Simpheropol Ukraine 95000
135 Research Facility Zaporizhzhya Ukraine 69050

Sponsors and Collaborators

  • Warner Chilcott

Investigators

  • Study Director: Piotr Krzeski, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00350415
Other Study ID Numbers:
  • 2006444
  • NCT00336440
First Posted:
Jul 10, 2006
Last Update Posted:
Apr 17, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Warner Chilcott
ulcerative colitis, inflammatory bowel disease
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Mesalamine

Study Results

No Results Posted as of Apr 17, 2013