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

Completed · Not applicable · Has a placebo group

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT00605826

Run by

Bausch Health Americas, Inc.

People needed

206

Starts

2006-09-07

Expected to finish

2009-11-23

Last updated by the study team

2020-08-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 years of age, male or female.
• Screening fecal incontinence severity score (CCFIS).
• Fecal incontinence episodes over a 14-day period.
• Failed conservative treatment for fecal incontinence.

You may not qualify if…

• Complete external sphincter disruption.
• Significant anorectal disease.
• Anorectal surgery within the last 12 months prior to the study.
• Active Inflammatory Bowel Disease (IBD).
• Immunodeficiency or receiving immunosuppressive therapy.
• Malignancies in remission for less than 2 years prior to the study.
• Bleeding disorders or receiving anticoagulant therapy.
• Chemotherapy within the last 12 months prior to the study.
• Prior Pelvic radiotherapy.
• Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
• Women within one year post partum.
• Participation in any other clinical study within 3 month prior to the study.
• Hypersensitivity to hyaluronic acid containing products.
• Other severe conditions or in other ways unsuitable to participate according to investigator judgement.

Where it is running

• University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery — San Francisco, California, United States
• University of South Florida College of Medicine, Tampa General Hospital — Tampa, Florida, United States
• Lahey Clinic, Department of Colon & Rectal Surgery — Burlington, Massachusetts, United States
• Colon & Rectal Surgery Associates — Minneapolis, Minnesota, United States
• St. Luke's/Roosevelt Hospital — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Colorectal Surgical Associates — Houston, Texas, United States
• Salt Lake Research/Center for Colon Rectal Disease — Salt Lake City, Utah, United States
• Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg — Erlangen, Germany
• Kirurgmottagningen Universitetssjukhuset MAS — Malmö, Sweden
• Kirurgmottagningen, Danderyds Sjukhus — Stockholm, Sweden
• Kirurgkliniken, Uppsala Akademiska Sjukhus — Uppsala, Sweden
• Castle Hill Hospital, Department of Academic Surgery — Cottingham, East Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.