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Clinical trial

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

NCT01008423 is registered in ClinicalTrials.gov with Bausch Health Americas, Inc. as lead sponsor.

NCT NCT01008423
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Bausch Health Americas, Inc.
Phase
Phase 3
Overall status
Completed
Start date
November 20, 2009
Completion date
March 18, 2013
Enrollment
281 (actual)
Sites
62

Conditions

As the registry lists them; a condition with its own page is linked.

proctitis, proctosigmoiditis