Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Natrogen Therapeutics International, Inc

Criteria

Inclusion Criteria:

• 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:

1. Newly diagnosed patients with moderate to severe ulcerative colitis evidenced by endoscopy and histopathology, who have never been medically treated for ulcerative colitis, or

2. 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

3. 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 Criteria:

• 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.