Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004056

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004056
  •   2012/07/31
  •   2008/01/09
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00605826  (ClinicalTrials.gov)
  •   33DA0404  (Q-Med Scandinavia, Inc.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Fecal Incontinence
  •   R15 -  Faecal incontinence
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Device: NASHA/Dx Injectable Gel
  •   Device: Sham Injection
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Proportion of subjects who are Responder50.; time frame: 6 months after last blinded treatment; 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; Proportion of subjects who achieve ≥ 25% reduction in the number of fecal incontinence episodes compared to baseline (Responder25).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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; Fecal Incontinence Quality of Life Scale (FIQL).
- Cleveland Clinic Florida Incontinence Score (CCFIS).; time frame: upto 36 months after last treatment; Cleveland Clinic Florida Incontinence Score (CCFIS).
- Adverse Events; time frame: 6 months after last blinded treatment and upto 36 months after last treatmtent; Adverse events reported during the 6 month blinded phase of the study.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Germany
  •   Sweden
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2006/08/31
  •   200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Q-Med Scandinavia, Inc.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.