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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Q-Med Scandinavia, Inc..
Recruitment status was  Active, not recruiting
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

January 9, 2008
July 13, 2011
August 2006
December 2009   (final data collection date for primary outcome measure)
  • 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).
Number of fecal incontinence episodes [ Time Frame: 6 months after last blinded treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00605826 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence

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.

Subjects in the sham control group will have the option to receive open-label treatment with NASHA/Dx after the blinded phase.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinence
  • Device: NASHA/Dx Injectable Gel
    Injection of 4 x 1ml of NASHA/Dx Gel
  • Device: Sham Injection
    Sham injection
  • Experimental: 1
    Blinded injection of NASHA/Dx Gel
    Intervention: Device: NASHA/Dx Injectable Gel
  • Sham Comparator: 2
    Blinded sham injection
    Intervention: Device: Sham Injection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2011
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Sweden,   United Kingdom
 
NCT00605826
33DA0404
No
John W Egan, Director, Medical Affairs & Clinical Research, Oceana Therapeutics, Inc.
Q-Med Scandinavia, Inc.
  • Oceana Therapeutics, Inc.
  • Q-Med AB
Not Provided
Q-Med Scandinavia, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP