A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title: A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.

Clinical Trial Description

Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.

Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT00605826
• Study type: Interventional
• Source: Bausch Health Americas, Inc.
• Status: Completed
• Phase: N/A
• Start date: September 7, 2006
• Completion date: November 23, 2009