drugset / Trial / NCT01349673
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
Timeline
- Start
- 2011-05-31
- Primary completion
- 2014-12-31
- Completion
- 2014-12-31
Outcome
Outcome not reported
Stopped: “Terminated for non-safety reasons when Sponsor felt that sufficient long-term safety data was obtained.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 2 mg | Rectal |