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This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DB: OTG (Pre-Amend 3) | Experimental | Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks. |
|
| OL: OTG (Post-Amend 3) | Experimental | Open-Label Oxybutynin Chloride topical gel (OTG) (Pre & Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks. |
|
| DB: Placebo (Pre-Amend 3) | Placebo Comparator | Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | 10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 | The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary. | Baseline (Week 0) up to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6 | Pre-Amendment 3: Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data). | Baseline (Week 0) up to week 6 |
| Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University /ID# 236889 | Loma Linda | California | 92354 | United States | ||
| Child Hosp of Orange County,CA /ID# 237517 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19683731 | Background | Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
This 2-part pediatric study, was initiated as a double-blind (DB), placebo-controlled study with an open-label (OL) extension (Protocol Amendment 3). In Part 1 (Pre-Amendment 3), subjects were randomized into DB: Placebo (Pre-Amend 3) or DB: OTG (Pre-Amend 3) treatment groups for 6 weeks, then all subjects were placed into OL: OTG (Pre-Amend 3) for 8 weeks. In Part 2 (Post-Amendment 3), newly enrolled subjects were placed into OL: OTG (Post-Amend 3) for 14 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | DB: Placebo (Pre-Amend 3) | Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data. |
| FG001 | DB: OTG (Pre-Amend 3) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Pre-Amendment 3 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2022 | Aug 12, 2024 |
This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.
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Pre-Amendment 3: All subjects, site personnel and Watson and CRO personnel directly involved in the execution of the study were blinded. Post-Amendment 3: All subjects Open-label
|
| Placebo | Drug | Topical gel |
|
Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data). |
| Baseline (Week 0) up to Week 6 |
| Change From Baseline in Average Number of Catheterizations Per Day at Week 6 | Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data). | Baseline (Week 0) up to Week 6 |
| Orange |
| California |
| 92868 |
| United States |
| Children's Hospital Colorado - Aurora /ID# 237620 | Aurora | Colorado | 80045 | United States |
| Augusta University Medical Center /ID# 238188 | Augusta | Georgia | 30912-0004 | United States |
| University of Mississippi Medical Center /ID# 238065 | Jackson | Mississippi | 39216-4500 | United States |
| Albany Medical College /ID# 236880 | Albany | New York | 12208 | United States |
| Duke University /ID# 237494 | Durham | North Carolina | 27710 | United States |
| Duplicate_Oregon Health & Science University /ID# 234354 | Portland | Oregon | 97239-3011 | United States |
| Cook Children's Med. Center /ID# 237538 | Fort Worth | Texas | 76104 | United States |
| Child Hosp of the King's Dtr's /ID# 237799 | Norfolk | Virginia | 23507 | United States |
Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OTG for 8-week period to generate additional safety data. |
| FG002 | OL: OTG (Pre-Amend 3) | Following the DB Period: Subjects received Open-Label (OL) oxybutynin chloride gel (OTG) for 8 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. |
| FG003 | OL: OTG (Post-Amend 3) | Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. |
| COMPLETED |
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| NOT COMPLETED |
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| Open Label Pre-Amendment 3 |
|
|
| Open Label Post-Amendment 3 |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | DB: Placebo (Pre-Amend 3) | Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data. |
| BG001 | DB: OTG (Pre-Amend 3) | Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OTG for 8-week period to generate additional safety data. |
| BG002 | OL: OTG (Post-Amend 3) | Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. |
| BG003 | 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 | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Percent of Catheterizations without Leaking Week 0 (Baseline) | ITT Population | Mean | Standard Deviation | percentage of catheterizations wo leak |
|
| 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 | Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 | The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary. | ITT Population | Posted | Mean | Standard Deviation | percentage of point | Baseline (Week 0) up to Week 6 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6 | Pre-Amendment 3: Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data). | ITT Population | Posted | Mean | Standard Deviation | mL | Baseline (Week 0) up to week 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6 | Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data). | ITT Population | Posted | Mean | Standard Deviation | mL | Baseline (Week 0) up to Week 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Number of Catheterizations Per Day at Week 6 | Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data). | ITT | Posted | Mean | Standard Error | Number of Catheterizations Per Day | Baseline (Week 0) up to Week 6 |
|
All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively.
Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
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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 | DB: Placebo (Pre-Amend 3) | Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data. | 0 | 16 | 0 | 16 | 8 | 16 |
| EG001 | DB: OTG (Pre-Amend 3) | Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period to generate additional safety data. | 0 | 17 | 0 | 17 | 12 | 17 |
| EG002 | OL: OTG (Pre-Amend 3) | Subjects received Open-Label (OL) oxybutynin chloride gel (OTG) for 8 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. | 0 | 33 | 3 | 33 | 16 | 33 |
| EG003 | OL: OTG (Post-Amend 3) | Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day | 0 | 19 | 3 | 19 | 15 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| LIMB DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DEVICE MALFUNCTION | Product Issues | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TACHYCARDIA | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| OPTIC DISC DRUSEN | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANAL INCONTINENCE | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| FEELING HOT | General disorders | MedDRA 26.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ASYMPTOMATIC BACTERIURIA | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| EAR INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| URINARY TRACT INFECTION ENTEROCOCCAL | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| VIRAL PHARYNGITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| SCRATCH | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| SKIN WOUND | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 26.1 | Systematic Assessment |
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| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA 26.1 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 26.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| JOINT CONTRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| TENDINOUS CONTRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| ATTENTION DEFICIT HYPERACTIVITY DISORDER | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| BLADDER DISCOMFORT | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| MICTURITION URGENCY | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| URINE ABNORMALITY | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| GENITAL RASH | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
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| VULVOVAGINAL ERYTHEMA | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| COLOSTOMY | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
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| FLUSHING | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
AbbVie has decided to discontinue further subject enrollment in the OG09002 (Oxybutynin) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2022 | Aug 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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| OG003 | Combined OTG | All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period. |
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| OG003 | Combine OTG | All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period. |
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