Clinical trial NCT00605826: A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
Official title: A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Oceana Therapeutics, Inc.
name: Galderma R&D
First posted: 2008-01-31
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Who Are Responder50.
timeFrame: 6 months after last blinded treatment
measure: Percentage of Participants Who Are Responder25.
timeFrame: 12 months after last treatment
Secondary outcomes:
measure: Number of Fecal Incontinence Episodes
timeFrame: up to 6 months after last treatment
measure: Number of Incontinence Free Days
timeFrame: up to 6 months after last treatment
measure: Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
timeFrame: up to 6 months after last treatment
measure: Cleveland Clinic Florida Incontinence Score (CCFIS).
timeFrame: up to 6 months after last treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
state: California
city: Tampa
country: United States
facility: University of South Florida College of Medicine, Tampa General Hospital
state: Florida
city: Burlington
country: United States
facility: Lahey Clinic, Department of Colon & Rectal Surgery
state: Massachusetts
city: Minneapolis
country: United States
facility: Colon & Rectal Surgery Associates
state: Minnesota
city: New York
country: United States
facility: St. Luke's/Roosevelt Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: Colorectal Surgical Associates
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research/Center for Colon Rectal Disease
state: Utah
city: Erlangen
country: Germany
facility: Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
city: Malmo
country: Sweden
facility: Kirurgmottagningen Universitetssjukhuset MAS
city: Stockholm
country: Sweden
facility: Kirurgmottagningen, Danderyds Sjukhus
city: Uppsala
country: Sweden
facility: Kirurgkliniken, Uppsala Akademiska Sjukhus
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital, Department of Academic Surgery
state: East Yorkshire
Study officials:
References:
citation: 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.