Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004024

Trial Description

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Title

An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in
the treatment of fecal incontinence for a total of 24 months after completed treatment.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004024
  •   2012/10/18
  •   2010/04/09
  •   no
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Secondary IDs

  •   NCT01110681  (ClinicalTrials.gov)
  •   33DA0605, Q-Med AB  (Q-Med AB)
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Health Condition or Problem studied

  •   Fecal Incontinence
  •   R15 -  Faecal incontinence
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Interventions/Observational Groups

  •   Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

- Number of fecal incontinence episodes; time frame: 12 months after last treatment

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Secondary Outcome

- Number of fecal incontinence episodes and incontinence-free days; time frame: up to 24 months after last treatment
- Fecal incontinence severity using the Cleveland Clinic Florida Incontinence Score; time frame: up to 24 months after last treatment; Cleveland Clinic Florida Incontinence Score (CCFIS) is a composite score of incontinence severity that measures the frequencies of gas leakage, leakage of solid or loose stool, use of protective pads and lifestyle alterations.
- Fecal Incontinence Quality of Life; time frame: up to 24 months after last treatment; Fecal Incontinence Quality of Life is a disease specific questionnaire with questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment.
- Number of subjects with Adverse Events as a measure of safety and tolerability; time frame: Up to 24 months after treatment

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Countries of Recruitment

  •   Canada
  •   Finland
  •   France
  •   Germany
  •   Italy
  •   Norway
  •   Spain
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Locations of Recruitment

  •  
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  •  
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Recruitment

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  •   2007/11/30
  •   115
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- 18-80 years of age, male or female

- Screening fecal incontinence severity score (CCFIS)

- Fecal incontinence episodes over a 28-day period

- Failed conservative treatment for fecal incontinence

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Exclusion Criteria

- Complete external sphincter disruption

- Significant anorectal disease

- Anorectal surgery within the last 12 months prior to the study

- Active Inflammatory Bowel Disease

- Immunodeficiency or receiving immunosuppressive therapy

- Malignancies in remission for less than 1 years prior to the study

- Bleeding disorders or receiving anticoagulant therapy

- Chemotherapy within the last 6 months prior to the study

- Prior Pelvic radiotherapy

- Pregnant or breast-feeding women, or women of childbearing potential not practicing
adequate contraception or planning to stop such contraception within the first year
of the study

- Women within 6 months post partum

- Participation in any other clinical study within 3 month prior to the study

- Other severe conditions or in other ways unsuitable to participate according to
investigator judgement

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Addresses

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    • Q-Med AB
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    • Q-Med AB
    • Head of Medical Affairs Q-Med AB 
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    • Q-Med AB
    • Head of Medical Affairs Q-Med AB 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/01
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Trial Publications, Results and other Documents

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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.