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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Oceana Therapeutics, Inc.

Q-Med AB

Information provided by:

Q-Med Scandinavia, Inc.

ClinicalTrials.gov Identifier:

NCT00605826

First received: January 9, 2008

Last updated: July 13, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 9, 2008
Last Updated Date	July 13, 2011
Start Date ^ICMJE	August 2006
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 13, 2011)	Proportion of subjects who are Responder50. [ Time Frame: 6 months after last blinded treatment ] [ Designated as safety issue: No ] Proportion of subjects who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50). Proportion of subjects who are Responder25. [ Time Frame: 12 months after last blinded treatment ] [ Designated as safety issue: No ] Proportion of subjects who achieve ≥ 25% reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
Original Primary Outcome Measures ^ICMJE (submitted: January 30, 2008)	Number of fecal incontinence episodes [ Time Frame: 6 months after last blinded treatment ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00605826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 13, 2011)	Number of fecal incontinence episodes [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ] Number of incontinence free days [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ] Fecal Incontinence Quality of Life Scale (FIQL). [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ] Fecal Incontinence Quality of Life Scale (FIQL). Cleveland Clinic Florida Incontinence Score (CCFIS). [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ] Cleveland Clinic Florida Incontinence Score (CCFIS). Adverse Events [ Time Frame: 6 months after last blinded treatment and upto 36 months after last treatmtent ] [ Designated as safety issue: Yes ] Adverse events reported during the 6 month blinded phase of the study.
Original Secondary Outcome Measures ^ICMJE (submitted: January 30, 2008)	Number of fecal incontinence episodes and incontinence free days [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ] Cleveland Clinic Florida Incontinence Score [ Time Frame: upto 36 months after last treatment ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
Official Title ^ICMJE	A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
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 in the sham control group will have the option to receive open-label treatment with NASHA/Dx after the blinded phase.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Fecal Incontinence
Intervention ^ICMJE	Device: NASHA/Dx Injectable Gel Injection of 4 x 1ml of NASHA/Dx Gel Device: Sham Injection Sham injection
Study Arm (s)	Experimental: 1 Blinded injection of NASHA/Dx Gel Intervention: Device: NASHA/Dx Injectable Gel Sham Comparator: 2 Blinded sham injection Intervention: Device: Sham Injection
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	December 2011
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00605826
Other Study ID Numbers ^ICMJE	33DA0404
Has Data Monitoring Committee	No
Responsible Party	John W Egan, Director, Medical Affairs & Clinical Research, Oceana Therapeutics, Inc.
Study Sponsor ^ICMJE	Q-Med Scandinavia, Inc.
Collaborators ^ICMJE	Oceana Therapeutics, Inc. Q-Med AB
Investigators ^ICMJE	Not Provided
Information Provided By	Q-Med Scandinavia, Inc.
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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