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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR ASACOL HD


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All Clinical Trials for Asacol Hd

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00007163 ↗ Monoclonal Antibody Treatment of Crohn's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2000-12-01 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 2000-09-01 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 2004-05-01 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 2005-03-01 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 2005-03-01 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.
NCT00151892 ↗ Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis Completed Shire Phase 3 2005-04-08 Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
NCT00194818 ↗ Asacol Dosing Study for Active Ulcerative Colitis Completed Procter and Gamble Phase 4 2003-06-01 We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on its ability to induce remission in patients with mild to moderately active ulcerative colitis. We hypothesize that both regimens will have the same efficacy and no difference in side effects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Asacol Hd

Condition Name

Condition Name for Asacol Hd
Intervention Trials
Ulcerative Colitis 19
Colitis, Ulcerative 5
Crohn Disease 2
Irritable Bowel Syndrome 1
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Condition MeSH

Condition MeSH for Asacol Hd
Intervention Trials
Colitis, Ulcerative 27
Ulcer 26
Colitis 26
Crohn Disease 3
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Clinical Trial Locations for Asacol Hd

Trials by Country

Trials by Country for Asacol Hd
Location Trials
United States 333
Canada 37
India 9
Germany 9
Romania 5
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Asacol Hd
Clinical Trial Phase Trials
Phase 4 3
Phase 3 20
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Asacol Hd
Clinical Trial Phase Trials
Completed 27
Terminated 4
Recruiting 2
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Clinical Trial Sponsors for Asacol Hd

Sponsor Name

Sponsor Name for Asacol Hd
Sponsor Trials
Warner Chilcott 9
Tillotts Pharma AG 6
Procter and Gamble 4
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Sponsor Type

Sponsor Type for Asacol Hd
Sponsor Trials
Industry 35
Other 23
NIH 1
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