Status:
UNKNOWN
Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
Lead Sponsor:
Natrogen Therapeutics International, Inc
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind,...
Detailed Description
This will be a randomized, double-blind, placebo-controlled, parallel-design study. Eligible patients will have moderate to severe ulcerative colitis, defined as: * A Disease Activity Index (DAI) sco...
Eligibility Criteria
Inclusion
- Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods.
- Subject is require to meet one of the following criteria:
- Newly diagnosed patients with moderate to severe ulcerative colitis evidenced by endoscopy and histopathology, who have never been medically treated for ulcerative colitis, or
- Patients with moderate to severe disease, as defined by a Disease Activity Index (DAI) score of 6-10 (inclusive) at the Baseline Visit (assessed at screening and verified at Day 1), with a negative evaluation of the terminal ileum within 3 years of the screening visit, or
- Patients with active ulcerative colitis who are refractory or intolerant to therapies of 5-ASA, steroids, immunosuppressants or anti-TNF-alpha.
- Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy, with a DAI mucosal appearance sub score ≥ 2.
- DAI rectal bleeding sub score of ≥ 1.
- Physician's Global Assessment (PGA) DAI sub score ≥ 2.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Ability to provide voluntary written informed consent.
- Adequate cardiac, renal and hepatic function as determined by site principal investigator and demonstrated by screening laboratory evaluations, and questionnaires, and physical examination results that are within normal limits.
Exclusion
- History of colonic or rectal surgery.
- Pregnant or breast-feeding.
- Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, or any other unstable medical condition.
- Known hypersensitivity to Natura alpha or any of the drug excipients.
- Active and chronic infections.
- Severe ulcerative colitis indicated by Disease Activity Index score \> 10.
- Patients with ulcerative proctitis (disease limited to less than 15 cm from the anal verge).
- Use of any vaccine or any other immunostimulator within 4 weeks prior to the screening visit. .
- Use of \> 2.4 gm mesalamine or equivalent within 2 weeks prior to the screening visit.
- Use of oral corticosteroids for more than 3 days during the two weeks prior to the screening visit.
- Use of corticosteroid or 5-ASA enemas, foams, or suppositories at any time within two weeks prior to the screening visit. .
- Use of TNF-alpha antibody or any other biologic therapy within 2 months prior to the screening visit. .
- Use of immunosuppressive drugs at any time within four weeks prior to the screening visit. .
- Use of oral or parenteral antibiotics at any time within two weeks prior to the screening visit.
- Diagnosis of Crohn's disease.
- Diagnosis of indeterminate colitis (inability to distinguish between ulcerative colitis and Crohn's disease).
- Diagnosis of microscopic colitis (collagenous or lymphocytic colitis).
- Diagnosis of ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis, or gonococcal proctitis.
- Diagnosis of Clostridium difficile colitis.
- History of positive serology to hepatitis B or C or human immunodeficiency virus (HIV) infection.
- Active alcohol or drug abuse.
- Known malignancy or history of malignancy that would reduce life expectancy.
- Current smoker, or has been a smoker within 6 months prior to the screening visit.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01216280
Start Date
July 1 2010
End Date
September 1 2011
Last Update
June 27 2011
Active Locations (10)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20814
3
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
4
AGA Medical Research Associates, LLC
Egg Harbor, New Jersey, United States, 08324