Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
Public ClinicalTrials.gov record NCT01586533. 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.
Official title
A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.
Study identification
- NCT ID
- NCT01586533
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- Jun 2012 (Type not available)
- Primary completion
- Apr 2014 (Estimated)
- Completion
- Not listed
- Last update posted
- Jan 8, 2014
Started 2012
United States locations
- U.S. sites
- 45
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates | Birmingham | Alabama | 35209 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80214 | — |
| Digestive Disease Associates | Gainesville | Florida | 32605 | — |
| Digestive Medical Associates | Hialeah | Florida | 33016 | — |
| The Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | — |
| Miami Gastroenterology Consultants P.A. | Miami | Florida | 33156 | — |
| South Medical Research Group | Miami | Florida | 33186 | — |
| Gastroenterology of Naples | Naples | Florida | 34102 | — |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | — |
| Shafran Gastroenterology | Winter Park | Florida | 32789 | — |
| Tri-County Research | Athens | Georgia | 30606 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| The Atlanta Center for Gastroenterology | Decatur | Georgia | 30033 | — |
| St. Josephs Candler Health System | Savannah | Georgia | 31405 | — |
| NCH Medical Group | Arlington Heights | Illinois | 60004 | — |
| Gastrointestinal Clinic of Quad Cities | Davenport | Iowa | 52807 | — |
| Professional Research Network of Kansas | Wichita | Kansas | 67203 | — |
| Clinical Trials Management of Louisiana | Metairie | Louisiana | 70006 | — |
| Dr. Jason Bozdin, M.D. | Berkley | Michigan | 48072 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Gregory Cammel, MD PLC | Wyoming | Michigan | 48418 | — |
| GI Associates and Endoscopy Center | Jackson | Mississippi | 39202 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Research Associates of New York | New York | New York | 10028 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| Carolina Digestive Health Associates | Davidson | North Carolina | 28036 | — |
| LeBauer Research Associates, P.A. | Greensboro | North Carolina | 27403 | — |
| Greater Cincinnati Gastroenterology | Cincinnati | Ohio | 45219 | — |
| Central Sooner Research | Norman | Oklahoma | 73071 | — |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| Gastroenterology United Tulsa | Tulsa | Oklahoma | 74135 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | — |
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
| Houston Digestive Disease Clinic | Houston | Texas | 77090 | — |
| Digestive Health Associates of Texas | Plano | Texas | 75075 | — |
| Advanced Research Institute | South Ogden | Utah | 84405 | — |
| New River Valley Research Institute | Christiansburg | Virginia | 24073 | — |
| Digestive & Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Digestive Disease Institute | Seattle | Washington | 98101 | — |
| Franciscan Research Center | Tacoma | Washington | 98405 | — |
| Wisconsin Center for Advanced Research | 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 NCT01586533, 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 Jan 8, 2014 · 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 NCT01586533 live on ClinicalTrials.gov.