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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR ASACOL

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Clinical Trials for Asacol

Trial ID Title Status Sponsor Phase Summary
NCT00007163 Monoclonal Antibody Treatment of Crohn's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This study will examine the safety and effectiveness of an experimental drug called J695 for treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine), 5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many patients do not respond adequately to treatment or they develop severe side effects from the medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical to a human antibody but chemically changed so that it can attach to and eliminate an inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can also heal inflammation that has already developed. Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and possibly a review of medical records. They will complete a Crohn's Disease Activity Index Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment groups, as follows: Group 1 Patients in this group will receive an injection of either J695 or placebo (a solution that does not contain any active medicine) under the skin on day 1 of the study, on day 29, and then weekly for a total of seven injections. After the last injection, patients will be followed for an additional 18 weeks. They will be monitored periodically throughout the study with physical examinations, disease activity index scores, and blood and urine tests. Group 2 Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections. They will be followed for an additional 18 weeks. Patients will be monitored as described above for group 1. Participants may be asked to undergo additional tests as part of a sub-study in this protocol. These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation.
NCT00073021 Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis Completed Warner Chilcott Phase 3 This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
NCT00092508 CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission Completed Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 3 This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.
NCT00094458 Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC Completed Schering-Plough Phase 3 The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
NCT00094458 Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC Completed Centocor Ortho Biotech Services, L.L.C. Phase 3 The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Asacol

Condition Name

Condition Name for Asacol
Intervention Trials
Ulcerative Colitis 16
Colitis, Ulcerative 4
Crohn Disease 2
Crohn's Disease 1
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Condition MeSH

Condition MeSH for Asacol
Intervention Trials
Colitis 24
Ulcer 24
Colitis, Ulcerative 24
Crohn Disease 3
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Clinical Trial Locations for Asacol

Trials by Country

Trials by Country for Asacol
Location Trials
United States 332
Canada 37
Germany 9
India 8
Romania 5
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Trials by US State

Trials by US State for Asacol
Location Trials
Florida 15
Texas 14
New York 14
California 13
Illinois 12
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Clinical Trial Progress for Asacol

Clinical Trial Phase

Clinical Trial Phase for Asacol
Clinical Trial Phase Trials
Phase 4 3
Phase 3 19
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Asacol
Clinical Trial Phase Trials
Completed 25
Recruiting 3
Terminated 2
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Clinical Trial Sponsors for Asacol

Sponsor Name

Sponsor Name for Asacol
Sponsor Trials
Warner Chilcott 9
Tillotts Pharma AG 6
Procter and Gamble 3
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Sponsor Type

Sponsor Type for Asacol
Sponsor Trials
Industry 32
Other 18
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Healthtrust
Julphar
McKesson
Chubb
Argus Health
Harvard Business School
Mallinckrodt

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