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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after last treatment compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fecal Incontinence Episodes. | Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month). | at 12 month - change from baseline |
| Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Affairs Q-Med AB | Galderma R&D | Study Director |
| Tom Oresland, MD | Akershus University Hospital, Lorenskog, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | V6Z1Y6 | Canada | |||
| Helsingin yliopistollinen keskussairaala |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solesta | Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solesta | Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values. | Posted | Number | 95% Confidence Interval | percentage of responders | 12 months after last treatment compared to baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solesta | Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perineal abscess | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctalgia | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Q-Med AB | + 46 (0)18 4749000 | reception.SEUPP@galderma.com |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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. |
| 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. | 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). | At 12 month- change from baseline |
| HUS |
| 00029 |
| Finland |
| CHU-Hotel-Dieu | Nantes | 44093 | France |
| Hôpital Saint Joseph | Paris | 75674 | France |
| CHU de Rouen 1 rue Germont service de chirurgie et digestive | Rouen | 76031 | France |
| Koloproktologische Praxis | Kiel | 24105 | Germany |
| Klinik für Allgemein- und Vizeralchirurgie | Ludwigsburg | 71640 | Germany |
| Enddarmzentrum Mannheim | Mannheim | 68165 | Germany |
| University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza | Bari | 70124 | Italy |
| Univ. degli Studi di Padova Hospital Clinica Chirurgica | Padova | 35128 | Italy |
| Policlinico Umberto I | Rome | 00161 | Italy |
| Akershus universitetssykehus | Nordbyhagen | 1474 | Norway |
| Hospital Clinic Provincial | Barcelona | 08036 | Spain |
| Hospital Juan Ramón Jiménez | Huelva | 21005 | Spain |
| Hospital General Univ. de Valéncia | Valencia | 46014 | Spain |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Fecal Incontinence Episodes. | Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month). | Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values. | Posted | Mean | Full Range | episodes | at 12 month - change from baseline |
|
|
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| Secondary | 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. | Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values. | Posted | Mean | Full Range | units on a scale | 12 month - change from baseline |
|
|
|
| Secondary | 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. | Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values. | Posted | Mean | Full Range | score on a scale | At 12 month - change from baseline |
|
|
|
| Secondary | Number of Incontinence-free Days | Number of incontinence-free days, change from baseline (change in patient diary data at 12 month). | Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values. | Posted | Mean | Full Range | days | At 12 month- change from baseline |
|
|
|
| 19 |
| 115 |
| 20 |
| 115 |
| Rectovaginal septum abscess | Infections and infestations |
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| Rectal abscess | Infections and infestations |
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| Rectal prolapse | Gastrointestinal disorders |
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| Rectal hemorrhage | Gastrointestinal disorders |
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| Proctalgia | Gastrointestinal disorders |
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| Abdominal pain | Gastrointestinal disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Breast infection | Infections and infestations |
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| Cardiac failure acute | Cardiac disorders |
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| Cholecystitis | Hepatobiliary disorders |
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| Cholecystitis acute | Hepatobiliary disorders |
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| Constipation | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Fecal incontinence | Gastrointestinal disorders |
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| Gastroenteritis | Gastrointestinal disorders |
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| Hemorrhoidal haemorrhage | Gastrointestinal disorders |
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| Hypothyriodism | Endocrine disorders |
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| Polycystic liver disease | Hepatobiliary disorders |
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| Postmenopausal hemorrhage | Reproductive system and breast disorders |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders |
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| Sjögrens syndrome | Immune system disorders |
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| Pyrexia | General disorders |
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| Title | Measurements |
|---|---|
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| Embarrassment |
|