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Sponsored by: |
Hollis-Eden Pharmaceuticals |
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Information provided by: | Hollis-Eden Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00628433 |
The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Placebo Drug: HE3286 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3286 When Administered Orally to Patients With Active, Mild-to-Moderate Ulcerative Colitis |
Estimated Enrollment: | 36 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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2: Experimental
HE3286 5 mg daily
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Drug: HE3286
daily for 28 days
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3: Experimental
HE3286 10 mg daily
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Drug: HE3286
daily for 28 days
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4: Experimental
HE3286 20 mg daily
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Drug: HE3286
daily for 28 days
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5: Experimental
HE3286 4 mg daily
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Drug: HE3286
daily for 28 days
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HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with ulcerative colitis. In preclinical experiments, HE3286 has shown activity in animal models of ulcerative colitis. Additionally, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects associated with corticosteroid use, such as immune suppression and bone loss.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hollis-Eden Pharmaceuticals Clinical Trials | 858-320-2591 | clinicaltrials@holliseden.com |
United States, Arizona | |
Recruiting | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Recruiting | |
La Jolla, California, United States, 92037 | |
Recruiting | |
Anaheim, California, United States, 92801 | |
Recruiting | |
Fresno, California, United States, 93726 | |
United States, Colorado | |
Recruiting | |
Denver, Colorado, United States, 80205 | |
Recruiting | |
Denver, Colorado, United States, 80215 | |
United States, Florida | |
Recruiting | |
Winter Park, Florida, United States, 32789 | |
United States, Georgia | |
Recruiting | |
Atlanta, Georgia, United States, 30342 | |
United States, Kentucky | |
Recruiting | |
Louisville, Kentucky, United States, 40536 | |
United States, Texas | |
Recruiting | |
El Paso, Texas, United States, 79905 |
Principal Investigator: | Dwight R Stickney, MD | Hollis-Eden Pharmaceuticals |
Responsible Party: | Hollis-Eden Pharmaceuticals ( Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality ) |
Study ID Numbers: | HE3286-0301 |
Study First Received: | February 25, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00628433 History of Changes |
Health Authority: | United States: Food and Drug Administration |
phase I/II ulcerative colitis safety tolerance pharmacokinetics |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |