A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
NCT ID: NCT00605826
Last Updated: 2020-08-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
206 participants
INTERVENTIONAL
2006-09-07
2009-11-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
NCT00971269
Study to Evaluate Solesta for Treatment of Fecal Incontinence
NCT01110681
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
NCT01647906
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
NCT01380132
Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
NCT02292628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Blinded injection of NASHA/Dx gel at randomization.
Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months).
NASHA/Dx (Solesta) Gel
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Blinded sham inject. at randomization
Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase.
Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).
Sham Injection
Sham injection at the start of the blinded phase.
Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.
Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase.
Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).
NASHA/Dx (Solesta) Gel
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Sham Injection
Sham injection at the start of the blinded phase.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NASHA/Dx (Solesta) Gel
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Sham Injection
Sham injection at the start of the blinded phase.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Screening fecal incontinence severity score (CCFIS).
* Fecal incontinence episodes over a 14-day period.
* Failed conservative treatment for fecal incontinence.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oceana Therapeutics, Inc.
INDUSTRY
Galderma R&D
INDUSTRY
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Malmo, , Sweden
Kirurgmottagningen, Danderyds Sjukhus
Stockholm, , Sweden
Kirurgkliniken, Uppsala Akademiska Sjukhus
Uppsala, , Sweden
Castle Hill Hospital, Department of Academic Surgery
Cottingham, East Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
33DA0404
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.