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

NCT01216280 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2011-06-27

No results posted yet for this study

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

Interventions

DRUG

placebo capsule

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

DRUG

10 mg Natura-alpha capsule and 10 mg placebo capsule

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

DRUG

2 x 10 mg Natura-alpha capsules

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

Sponsors & Collaborators

  • Natrogen Therapeutics International, Inc

    lead INDUSTRY

Principal Investigators

  • Longgui Wang, MD · Natrogen Therapeutics International, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216280 on ClinicalTrials.gov