Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT01216280. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01216280
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Interventions
- placebo capsule Drug
- 10 mg Natura-alpha capsule and 10 mg placebo capsule Drug
- 2 x 10 mg Natura-alpha capsules Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2010 (Type not available)
- Primary completion
- Jul 2011 (Estimated)
- Completion
- Sep 2011 (Estimated)
- Last update posted
- Jun 27, 2011
2010 – 2011
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20814 | — |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | — |
| AGA Medical Research Associates, LLC | Egg Harbor | New Jersey | 08324 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Consultants for Clinical Research | Fairfield | Ohio | 45014 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Wisconsin Center for Advanced Research, LLC | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01216280, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2011 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01216280 live on ClinicalTrials.gov.