A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
This study is ongoing, but not recruiting participants.
Sponsor:
Q-Med Scandinavia, Inc.
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
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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
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 May 21, 2013