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

NCT00605826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2020-08-18

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

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.

Sponsors & Collaborators

  • Oceana Therapeutics, Inc.

    collaborator INDUSTRY

  • Galderma R&D

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-07
Primary Completion
2009-11-23
Completion
2009-11-23

Countries

  • United States
  • Germany
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00605826 on ClinicalTrials.gov