This trial is active, not recruiting.

Condition fecal incontinence
Treatments nasha/dx injectable gel, sham injection
Sponsor Q-Med Scandinavia, Inc.
Collaborator Oceana Therapeutics, Inc.
Start date August 2006
End date December 2009
Trial size 200 participants
Trial identifier NCT00605826, 33DA0404


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Blinded injection of NASHA/Dx Gel
nasha/dx injectable gel
Injection of 4 x 1ml of NASHA/Dx Gel
(Sham Comparator)
Blinded sham injection
sham injection
Sham injection

Primary Outcomes

Proportion of subjects who are Responder50.
time frame: 6 months after last blinded treatment
Proportion of subjects who are Responder25.
time frame: 12 months after last blinded treatment

Secondary Outcomes

Number of fecal incontinence episodes
time frame: upto 36 months after last treatment
Number of incontinence free days
time frame: upto 36 months after last treatment
Fecal Incontinence Quality of Life Scale (FIQL).
time frame: upto 36 months after last treatment
Cleveland Clinic Florida Incontinence Score (CCFIS).
time frame: upto 36 months after last treatment
Adverse Events
time frame: 6 months after last blinded treatment and upto 36 months after last treatmtent

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Description Subjects in the sham control group will have the option to receive open-label treatment with NASHA/Dx after the blinded phase.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Q-Med Scandinavia, Inc..