Fecal IncontinenceNCT01110681
Study to Evaluate Solesta for Treatment of Fecal Incontinence
A study testing Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) in people with Fecal Incontinence, run by Galderma R&D at 15 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Nov 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
France3 sites
CHU-Hotel-Dieu
Nantes, 44093
Hôpital Saint Joseph
Paris, 75674
CHU de Rouen 1 rue Germont service de chirurgie et digestive
Rouen, 76031
Germany3 sites
Koloproktologische Praxis
Kiel, 24105
Klinik für Allgemein- und Vizeralchirurgie
Ludwigsburg, 71640
Enddarmzentrum Mannheim
Mannheim, 68165
Italy3 sites
University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza
Bari, 70124
Univ. degli Studi di Padova Hospital Clinica Chirurgica
Padova, 35128
Policlinico Umberto I
Rome, 00161
Spain3 sites
Hospital Clinic Provincial
Barcelona, 08036
Hospital Juan Ramón Jiménez
Huelva, 21005
Hospital General Univ. de Valéncia
Valencia, 46014
About this study
Official title: An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
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.
- Conditions
- Fecal Incontinence
- Being tested
- Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)Device
Also called Solesta
| Study group | Role | What they receive |
|---|---|---|
| Solesta | Experimental | Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) The study treatment consisted of 4 submucosal injections, 1 mL Solesta each, in the proximal part of the high pressure zone in the anal canal.
Re-treatment is allowed one month after initial treatment if the subject is still incontinent. Receives: Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate in Number of Fecal Incontinence Episodes
Responder rate in number of fecal incontinence episodes change from baseline at 12 month.
Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline.
Measured: 12 months after last treatment compared to baseline
Secondary outcomes (4)
Number of Fecal Incontinence Episodes.
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
Measured: at 12 month - change from baseline
Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
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. The score ranges from 0 (representing complete continence)to 20 (representing complete incontinence).
Change from baseline.
Measured: 12 month - change from baseline
Fecal Incontinence Quality of Life (FIQL)
Fecal Incontinence Quality of Life is a disease specific questionnaire composed of a total of 29 questions questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment. The FIQL mean score ranges from 1 to 4 for the Lifestyle, Coping/Behavior and Embarrassment domains, and from 1 to 4.429 for Depression/Self-Perception domain. Mean score were calculated for each of the four domains. The more the subject is affected by fecal incontinence the lower value. Change from baseline.
Measured: At 12 month - change from baseline
Number of Incontinence-free Days
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
Measured: At 12 month- change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Affairs Q-Med AB, Study director, Galderma R&DTom Oresland, MD, Principal investigator, Akershus University Hospital, Lorenskog, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110681
- Sponsor's protocol ID
- 33DA0605, Q-Med AB
- Status last verified
- Dec 2013
- First submitted
- 9 Apr 2010
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01110681
- Acronym / sponsor ID
- 33DA0605, Q-Med AB
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solesta | Experimental | Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) The study treatment consisted of 4 submucosal injections, 1 mL Solesta each, in the proximal part of the high pressure zone in the anal canal. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)Also: Solesta | Device | Solesta |
Primary outcome
Responder Rate in Number of Fecal Incontinence Episodes
Time frame: 12 months after last treatment compared to baseline
Responder rate in number of fecal incontinence episodes change from baseline at 12 month. Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline.
4 secondary outcomes
Number of Fecal Incontinence Episodes.
Time frame: at 12 month - change from baseline
Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
Time frame: 12 month - change from baseline
Fecal Incontinence Quality of Life (FIQL)
Time frame: At 12 month - change from baseline
Number of Incontinence-free Days
Time frame: At 12 month- change from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Medical Affairs Q-Med AB study director
Galderma R&D
Tom Oresland, MD principal investigator
Akershus University Hospital, Lorenskog, Norway
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) in people with Fecal Incontinence, run by Galderma R&D at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Germany, Italy, Spain, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate in Number of Fecal Incontinence Episodes (time frame: 12 months after last treatment compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.