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
  Purpose

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.


Condition Intervention
Fecal Incontinence
Device: NASHA/Dx Injectable Gel
Device: Sham Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Q-Med Scandinavia, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: August 2006
Estimated Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Blinded injection of NASHA/Dx Gel
Device: NASHA/Dx Injectable Gel
Injection of 4 x 1ml of NASHA/Dx Gel
Sham Comparator: 2
Blinded sham injection
Device: Sham Injection
Sham injection

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605826

Locations
United States, California
University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
San Francisco, California, United States, 94115
United States, Florida
University of South Florida College of Medicine, Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Massachusetts
Lahey Clinic, Department of Colon & Rectal Surgery
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Colon & Rectal Surgery Associates
Minneapolis, Minnesota, United States, 55454
United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10019
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
Colorectal Surgical Associates
Houston, Texas, United States, 77054
United States, Utah
Salt Lake Research/Center for Colon Rectal Disease
Salt Lake City, Utah, United States, 84107
Germany
Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
Erlangen, Germany, 910 54
Sweden
Kirurgmottagningen Universitetssjukhuset MAS
Malmo, Sweden, 205 02
Kirurgmottagningen, Danderyds Sjukhus
Stockholm, Sweden, 182 88
Kirurgkliniken, Uppsala Akademiska Sjukhus
Uppsala, Sweden, 751 85
United Kingdom
Castle Hill Hospital, Department of Academic Surgery
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Q-Med Scandinavia, Inc.
Oceana Therapeutics, Inc.
Q-Med AB
  More Information

No publications provided by Q-Med Scandinavia, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John W Egan, Director, Medical Affairs & Clinical Research, Oceana Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00605826     History of Changes
Other Study ID Numbers: 33DA0404
Study First Received: January 9, 2008
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Germany: German Institute of Medical Documentation and Information
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014