Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oceana Therapeutics, Inc. | INDUSTRY |
| Galderma R&D | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.
Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded injection of NASHA/Dx gel at randomization. | Experimental | Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months). |
|
| Blinded sham inject. at randomization | Sham Comparator | Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). |
|
| Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo. | Other | Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NASHA/Dx (Solesta) Gel | Device | Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Responder50. | Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50). | 6 months after last blinded treatment |
| Percentage of Participants Who Are Responder25. | Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25). | 12 months after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fecal Incontinence Episodes | The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits. | up to 6 months after last treatment |
| Number of Incontinence Free Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21420555 | Derived | Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NashaDx/Fecal | NashaDx/Fecal - 4 syringes each containing 1 mL of product |
| FG001 | Sham | Sham - 4 empty syringes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Injection | Device | Sham injection at the start of the blinded phase. |
|
The number of days with no fecal incontinence episodes (incontinence free days). |
| up to 6 months after last treatment |
| Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4. | up to 6 months after last treatment |
| Cleveland Clinic Florida Incontinence Score (CCFIS). | Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence) | up to 6 months after last treatment |
| University of South Florida College of Medicine, Tampa General Hospital | Tampa | Florida | 33601 | United States |
| Lahey Clinic, Department of Colon & Rectal Surgery | Burlington | Massachusetts | 01805 | United States |
| Colon & Rectal Surgery Associates | Minneapolis | Minnesota | 55454 | United States |
| St. Luke's/Roosevelt Hospital | New York | New York | 10019 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Colorectal Surgical Associates | Houston | Texas | 77054 | United States |
| Salt Lake Research/Center for Colon Rectal Disease | Salt Lake City | Utah | 84107 | United States |
| Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg | Erlangen | 910 54 | Germany |
| Kirurgmottagningen Universitetssjukhuset MAS | Malmö | 205 02 | Sweden |
| Kirurgmottagningen, Danderyds Sjukhus | Stockholm | 182 88 | Sweden |
| Kirurgkliniken, Uppsala Akademiska Sjukhus | Uppsala | 751 85 | Sweden |
| Castle Hill Hospital, Department of Academic Surgery | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NashaDx/Fecal | NashaDx/Fecal - 4 syringes each containing 1 mL of product |
| BG001 | Sham | Sham - 4 empty syringes |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants Who Are Responder50. | Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50). | Posted | Count of Participants | Participants | 6 months after last blinded treatment |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Are Responder25. | Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25). | This outcome measure was only analyzed for the NASHA/Dx group. | Posted | Number | percentage of participants | 12 months after last treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Fecal Incontinence Episodes | The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits. | Posted | Mean | Standard Error | number of episodes | up to 6 months after last treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Incontinence Free Days | The number of days with no fecal incontinence episodes (incontinence free days). | Posted | Mean | 95% Confidence Interval | incontinence free days | up to 6 months after last treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4. | This outcome measure was only analyzed for the NASHA/Dx group. | Posted | Mean | Standard Error | units on a scale | up to 6 months after last treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Cleveland Clinic Florida Incontinence Score (CCFIS). | Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence) | This outcome measure was only analyzed for the NASHA/Dx group. | Posted | Mean | Standard Error | units on a scale | up to 6 months after last treatment |
|
|
36 months
Adverse events were assessed in all treated subjects and not by treatment group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | Adverse events were assessed overall and not by randomized treatment group | 31 | 206 | 78 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arterial senosis limb | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Back pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Carotid artery stenosis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Enterocele | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Multiple endocrine adenomatosis Type II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rectal abscess | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| E. coli bacteremia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haemorrhage | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|