Proctitis Clinical Trial
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
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).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01966783 -
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
|
Phase 2 | |
| Completed |
NCT01008410 -
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
|
Phase 3 | |
| Terminated |
NCT01349673 -
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
|
Phase 3 | |
| Terminated |
NCT01172444 -
Clinical Trial With Mesalamine 1g Suppositories
|
Phase 3 | |
| Completed |
NCT01837615 -
Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
|
Phase 2 |