NCT00605826

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	NASHA/Dx (Solesta) Gel	Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
DEVICE	Sham Injection	Sham injection at the start of the blinded phase.

Timeline

• Start date: 2006-09-07
• Primary completion: 2009-11-23
• Completion: 2009-11-23
• First posted: 2008-01-31
• Last updated: 2020-08-18
• Results posted: 2020-08-18

Locations

13 sites across 4 countries: United States, Germany, Sweden, United Kingdom