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2 x 10 mg Natura-alpha capsules for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Natrogen Therapeutics International, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

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.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physician's Global Assessment(PGA)
Secondary outcome measures
Physician's Global Assessment (PGA)
Safety

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2 x 10 mg Natura-alpha capsulesExperimental Treatment1 Intervention
2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.
Group II: 10mg Natura-alpha + 10 mg placeboExperimental Treatment1 Intervention
10 mg Natura-alpha capsule + 10 mg placebo capsule administered orally with water, b.i.d.
Group III: 2 x 10 mg placebo capsulePlacebo Group1 Intervention
2 x 10 mg placebo capsules, administered orally with water, b.i.d.

Find a Location

Who is running the clinical trial?

Natrogen Therapeutics International, IncLead Sponsor
Longgui Wang, MDStudy DirectorNatrogen Therapeutics International, Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
2010. "Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01216280.
All > Ulcerative Colitis > Colitis
~5 spots leftby Apr 2025
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