At a glance
ClinicalIndex Comparison RecordN/ACompleted· 206 enrolled
Drug / intervention
NASHA/Dx (Solesta) Gel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
In Brief
A clinical study evaluating NASHA/Dx (Solesta) Gel and Sham Injection for Fecal Incontinence. Completed, enrolled 206 participants across 13 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesGermany, Sweden, United Kingdom, United States
CollaboratorsOceana Therapeutics, Inc., Galderma R&D
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedJan 2008
Primary CompletionNov 2009
TodayJul 2026
First PostedJan 31, 2008
Enrollment StartSep 7, 2006
Primary CompletionNov 23, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.4 years ago
Interventions
NASHA/Dx (Solesta) Geldevice
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Sham Injectiondevice
Sham injection at the start of the blinded phase.