Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Public ClinicalTrials.gov record NCT01008410. 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 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
Study identification
- NCT ID
- NCT01008410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 265 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 17, 2009 (Actual)
- Primary completion
- Apr 29, 2013 (Actual)
- Completion
- Apr 29, 2013 (Actual)
- Last update posted
- Aug 14, 2019
2009 – 2013
United States locations
- U.S. sites
- 63
- U.S. states
- 26
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Huntsville | Alabama | — | — |
| Not listed | Jonesboro | Arkansas | — | — |
| Not listed | National City | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | San Carlos | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Lakewood | Colorado | — | — |
| Not listed | Littleton | Colorado | — | — |
| Not listed | Bridgeport | Connecticut | — | — |
| Not listed | Boynton Beach | Florida | — | — |
| Not listed | Hollywood | Florida | — | — |
| Not listed | Inverness | Florida | — | — |
| Not listed | Largo | Florida | — | — |
| Not listed | Maitland | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | New Smyrna Beach | Florida | — | — |
| Not listed | Port Orange | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Trinity | Florida | — | — |
| Not listed | Zephyrhills | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Newnan | Georgia | — | — |
| Not listed | Bolingbrook | Illinois | — | — |
| Not listed | Clive | Iowa | — | — |
| Not listed | Baton Rouge | Louisiana | — | — |
| Not listed | Shreveport | Louisiana | — | — |
| Not listed | Lutherville | Maryland | — | — |
| Not listed | Weymouth | Massachusetts | — | — |
| Not listed | Troy | Michigan | — | — |
| Not listed | Wyoming | Michigan | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Mexico | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Elizabeth | New Jersey | — | — |
| Not listed | Vineland | New Jersey | — | — |
| Not listed | Lake Success | New York | — | — |
| Not listed | Boone | North Carolina | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Huntersville | North Carolina | — | — |
| Not listed | LaPorte | North Carolina | — | — |
| Not listed | Morganton | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Gallipolis | Ohio | — | — |
| Not listed | Mentor | Ohio | — | — |
| Not listed | Norman | Oklahoma | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Columbia | South Carolina | — | — |
| Not listed | Franklin | Tennessee | — | — |
| Not listed | Germantown | Tennessee | — | — |
| Not listed | Jackson | Tennessee | — | — |
| Not listed | Kingsport | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Plano | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Tyler | Texas | — | — |
| Not listed | Bellevue | Washington | — | — |
| Not listed | Vancouver | Washington | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
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 NCT01008410, 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 14, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01008410 live on ClinicalTrials.gov.