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

NCT01216280 | Unknown Phase 2

• 2 other identifiers: NTI-2009-UC170984
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

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, 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.

Conditions

Ulcerative Colitis

Keywords

Natura-alpha; ulcerative colitis; cytokines; Th1; Th17

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment(PGA)

  The primary efficacy endpoint will be the proportion of patients in all treatment groups with clinical response (improvement) at Day 28.

  Day 28 after the treatment

Secondary Outcomes (5)

• Physician's Global Assessment (PGA)

  Day 28 after the treatment

• Physician's Global Assessment (PGA)

  Day 7

• Physician's Global Assessment (PGA)

  14

• Physician's Global Assessment (PGA)

  Day 28

• Safety

  Day 28

Study Arms (3)

2 x 10 mg placebo capsule

PLACEBO COMPARATOR

2 x 10 mg placebo capsules, administered orally with water, b.i.d.

Drug: placebo capsule

10mg Natura-alpha + 10 mg placebo

EXPERIMENTAL

10 mg Natura-alpha capsule + 10 mg placebo capsule administered orally with water, b.i.d.

Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule

2 x 10 mg Natura-alpha capsules

EXPERIMENTAL

2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.

Drug: 2 x 10 mg Natura-alpha capsules

Interventions

placebo capsule DRUG

2 x 10 mg placebo capsules administered orally with water, b.i.d.

Also known as: Group 1

2 x 10 mg placebo capsule

10 mg Natura-alpha capsule and 10 mg placebo capsule DRUG

10 mg Natura-alpha capsule and 10 mg placebo capsule administered orally with water, b.i.d.

Also known as: Group 2

10mg Natura-alpha + 10 mg placebo

2 x 10 mg Natura-alpha capsules DRUG

2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.

Also known as: Group 3

2 x 10 mg Natura-alpha capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natrogen Therapeutics International, Inc: lead

Study Sites (10)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20814, United States

Location

Kansas City Gastroenterology and Hepatology

Kansas City, Missouri, 64131, United States

Location

AGA Medical Research Associates, LLC

Egg Harbor, New Jersey, 08324, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Consultants for Clinical Research

Fairfield, Ohio, 45014, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Wisconsin Center for Advanced Research, LLC

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

N-methyl-delta-3,3-dihydroindole-2,2 diketone

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Longgui Wang, MD

  Natrogen Therapeutics International, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: October 7, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2010-07

Locations

US (10)