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Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

NCT01380132 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-06-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Conditions

  • Fecal Incontinence

Interventions

PROCEDURE

Anal injection of Nasha Dx

Submucous injection of Nasha Dx 5-10 mm above dentate line

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Wilhelm JR Graf, Prof. · Inst of Surgical Sciences, Uppsala university

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2009-01-31
Completion
2009-05-31

Countries

  • Sweden

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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 NCT01380132 on ClinicalTrials.gov