Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Public ClinicalTrials.gov record NCT01016262. 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 Multicenter, Double-blind, Controlled, Randomized, Parallel Group Comparison Phase IIIa Treatment Investigation on the Efficacy and Safety of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
Study identification
- NCT ID
- NCT01016262
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 119 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Nov 30, 2009 (Actual)
- Primary completion
- Jul 31, 2011 (Actual)
- Completion
- Sep 30, 2011 (Actual)
- Last update posted
- Aug 28, 2019
2009 – 2011
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates P.C. | Birmingham | Alabama | 35209 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Desert Sun Gastroenterology | Tucson | Arizona | 85710 | — |
| Rocky Mountain Gastroenterology Associates | Thornton | Colorado | 80229 | — |
| Litchfield County Gastroenterology and Associates | Torrington | Connecticut | 06790 | — |
| Clinical Research of South Florida | Boynton Beach | Florida | 33426 | — |
| Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Digestive Research Associates | Newnan | Georgia | 30263 | — |
| Advanced Pain Care Clinic | Evansville | Indiana | 47714 | — |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | — |
| Center for Digestive & Liver Diseases Inc. | Mexico | Missouri | 65265 | — |
| South Jersey Gastroenterology | Marlton | New Jersey | 08053 | — |
| Synergy First Medical | Brooklyn | New York | 11230 | — |
| Research Associates of New York (RANY) | New York | New York | 10075 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | — |
| The First Clinic | Nashville | Tennessee | 37203 | — |
| South Texas Research Alliance | Laredo | Texas | 78041 | — |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01016262, 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 Aug 28, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01016262 live on ClinicalTrials.gov.