Trial Outcomes & Findings for Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream. (NCT NCT04534491)
NCT ID: NCT04534491
Last Updated: 2020-10-20
Results Overview
For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed "mitigation," because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.
COMPLETED
PHASE3
855 participants
Approximately 15 weeks from subjects' initial purchase of Oxytrol
2020-10-20
Participant Flow
Study was conducted in US-sites and pharmacies from 25May2010 (first patient first visit) to 22Jun2011 (last patient last visit).
Twelve hundred thirty (1230) women arrived at the pharmacies for the enrollment phase and 855 qualified participants purchased Oxytrol and entered the actual use phase.
Participant milestones
| Measure |
Oxybutynin (Oxytrol, BAY839380)
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Overall Study
STARTED
|
855
|
|
Overall Study
Treated
|
727
|
|
Overall Study
COMPLETED
|
703
|
|
Overall Study
NOT COMPLETED
|
152
|
Reasons for withdrawal
| Measure |
Oxybutynin (Oxytrol, BAY839380)
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Overall Study
Not completed end-of-study interview
|
24
|
|
Overall Study
Non-users
|
70
|
|
Overall Study
Non-verifiable users
|
58
|
Baseline Characteristics
727 verified users.
Baseline characteristics by cohort
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=855 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 15.0 • n=727 Participants • 727 verified users.
|
|
Sex: Female, Male
Female
|
727 Participants
n=727 Participants • 727 verified users.
|
|
Sex: Female, Male
Male
|
0 Participants
n=727 Participants • 727 verified users.
|
|
Race/Ethnicity, Customized
White
|
561 Participants
n=727 Participants • 727 verified users
|
|
Race/Ethnicity, Customized
Black or African American
|
66 Participants
n=727 Participants • 727 verified users
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
64 Participants
n=727 Participants • 727 verified users
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=727 Participants • 727 verified users
|
|
Race/Ethnicity, Customized
Other
|
24 Participants
n=727 Participants • 727 verified users
|
PRIMARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolFor each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed "mitigation," because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=727 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
The Percentage of Participants Who Did Not Stop Use When They Either Developed a New Symptom Referred to Anywhere in the Labeling or When Their Condition Worsened Including Abdominal and/or Pelvic Pain.
Pre-mitigation
|
14.4 Percentage of participants
Interval 12.0 to 17.2
|
|
The Percentage of Participants Who Did Not Stop Use When They Either Developed a New Symptom Referred to Anywhere in the Labeling or When Their Condition Worsened Including Abdominal and/or Pelvic Pain.
Post-mitigation
|
3.4 Percentage of participants
Interval 2.2 to 5.0
|
SECONDARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolThis outcome measure did not include participants who developed abdominal and/or pelvic pain and was more reflective of how consumers stopped use according to the symptoms described on the Oxytrol labeling used in the study.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=727 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
The Percentage of Verified Users Who Did Not Stop Use When Their Condition Worsened or They Developed a New Symptom Referred to in the Labeling.
Pre-Mitigation
|
13.1 Percentage of participants
Interval 10.7 to 15.7
|
|
The Percentage of Verified Users Who Did Not Stop Use When Their Condition Worsened or They Developed a New Symptom Referred to in the Labeling.
Post-Mitigation
|
3.2 Percentage of participants
Interval 2.0 to 4.7
|
SECONDARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolThis outcome measure evaluated the number of days it took for a subject to discontinue use of Oxytrol after their symptoms worsened or had stayed the same after 2 weeks of treatment. This was calculated using diary card data.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=187 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.
|
35 Days
Interval 26.0 to 46.0
|
SECONDARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolFactors considered in this mitigation included providing: a response to one or more open ended questions that indicated a thoughtful, informed reason for continuing use; the subject talked to a physician, and the physician advised the subject that it was acceptable to continue using product; the subject had improved by Week 7 and indicated a thoughtful, informed reason for continuing use; as well as other reasons explained in the guidelines. This outcome measure was analyzed based on pre- and post-mitigation assessments but the post-mitigation analysis includes all subject data and is a better reflection of the subject's overall behavior. This was calculated by dividing the total number of subjects by the number of subjects who used the Oxytrol patch at least once.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=643 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
All Subjects Pre-Mitigation
|
22.6 Percentage of participants
Interval 19.4 to 26.0
|
|
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
All Subjects Post-Mitigation
|
11.0 Percentage of participants
Interval 8.7 to 13.7
|
SECONDARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolPopulation: 324 participants continued Oxytrol therapy and experienced new symptoms of interest or whose OAB symptoms did not improve.
The medical risk of the newly developed symptom(s) or no sign of symptom improvement was categorized according to prospectively defined medical risk categories of 'medical risk', 'possible medical risk', and minimal/insignificant medical risk'. Mitigated data was not included in this endpoint.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=324 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Number of Participants With Medical Risk Associated With the Development of New Symptoms or When Symptoms Did Not Improve for Patients That Continued Oxytrol Treatment.
Medical risk (subjects)
|
16 Participants
|
|
Number of Participants With Medical Risk Associated With the Development of New Symptoms or When Symptoms Did Not Improve for Patients That Continued Oxytrol Treatment.
Possible medical risk (subjects)
|
24 Participants
|
|
Number of Participants With Medical Risk Associated With the Development of New Symptoms or When Symptoms Did Not Improve for Patients That Continued Oxytrol Treatment.
Minimal/insignificant medical risk (subjects)
|
284 Participants
|
SECONDARY outcome
Timeframe: Approximately 15 weeks from subjects' initial purchase of OxytrolFactors considered in this mitigation for incorrect duration included most of the duration of patch use being correct, subject indicated understanding of the label but perhaps forgetting for a patch or two, etc. Factors considered in mitigation for simultaneous use include obvious diary errors, a subject stating that she did not do this, or a subject's doctor telling her to wear two patches at a time.
Outcome measures
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=727 Participants
Subjects decided to purchase Oxytrol.
|
|---|---|
|
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
Total Subjects Pre-Mitigation
|
51.7 Percentage of participants
Interval 47.9 to 55.4
|
|
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
Total Subjects Post-Mitigation
|
21.2 Percentage of participants
Interval 18.3 to 24.4
|
Adverse Events
Oxybutynin (Oxytrol, BAY839380)
Serious adverse events
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=785 participants at risk
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.13%
1/785 • 15 weeks
|
|
Cardiac disorders
Cardiac disorder
|
0.13%
1/785 • 15 weeks
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.13%
1/785 • 15 weeks
|
|
General disorders
Chest pain
|
0.25%
2/785 • 15 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
2/785 • 15 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.13%
1/785 • 15 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.13%
1/785 • 15 weeks
|
|
Infections and infestations
Bronchitis
|
0.13%
1/785 • 15 weeks
|
|
Infections and infestations
Cellulitis
|
0.13%
1/785 • 15 weeks
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.13%
1/785 • 15 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.13%
1/785 • 15 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.38%
3/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.13%
1/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.13%
1/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
1/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/785 • 15 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
1/785 • 15 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy
|
0.13%
1/785 • 15 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/785 • 15 weeks
|
|
Nervous system disorders
Convulsion
|
0.13%
1/785 • 15 weeks
|
|
Nervous system disorders
Syncope
|
0.13%
1/785 • 15 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
1/785 • 15 weeks
|
|
Psychiatric disorders
Anxiety
|
0.13%
1/785 • 15 weeks
|
|
Psychiatric disorders
Depression
|
0.13%
1/785 • 15 weeks
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.13%
1/785 • 15 weeks
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.13%
1/785 • 15 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.13%
1/785 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.13%
1/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.13%
1/785 • 15 weeks
|
|
Vascular disorders
Thrombosis
|
0.13%
1/785 • 15 weeks
|
Other adverse events
| Measure |
Oxybutynin (Oxytrol, BAY839380)
n=785 participants at risk
Subjects decided to purchase Oxytrol.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
2/785 • 15 weeks
|
|
Eye disorders
Cataract
|
0.64%
5/785 • 15 weeks
|
|
Eye disorders
Dry eye
|
1.3%
10/785 • 15 weeks
|
|
Eye disorders
Vision blurred
|
0.64%
5/785 • 15 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.38%
3/785 • 15 weeks
|
|
Eye disorders
Visual impairment
|
0.25%
2/785 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.25%
2/785 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
5/785 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.64%
5/785 • 15 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.5%
20/785 • 15 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
16/785 • 15 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
32/785 • 15 weeks
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.25%
2/785 • 15 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.38%
3/785 • 15 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.0%
16/785 • 15 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.38%
3/785 • 15 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
2/785 • 15 weeks
|
|
General disorders
Application site erythema
|
1.1%
9/785 • 15 weeks
|
|
General disorders
Application site irritation
|
18.1%
142/785 • 15 weeks
|
|
General disorders
Application site pruritus
|
1.0%
8/785 • 15 weeks
|
|
General disorders
Application site rash
|
0.51%
4/785 • 15 weeks
|
|
General disorders
Application site reaction
|
1.7%
13/785 • 15 weeks
|
|
General disorders
Fatigue
|
1.4%
11/785 • 15 weeks
|
|
General disorders
Irritability
|
0.38%
3/785 • 15 weeks
|
|
General disorders
Oedema peripheral
|
0.51%
4/785 • 15 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.89%
7/785 • 15 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.38%
3/785 • 15 weeks
|
|
Infections and infestations
Bronchitis
|
1.3%
10/785 • 15 weeks
|
|
Infections and infestations
Cystitis
|
2.0%
16/785 • 15 weeks
|
|
Infections and infestations
Diverticulitis
|
0.38%
3/785 • 15 weeks
|
|
Infections and infestations
Fungal infection
|
0.76%
6/785 • 15 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
8/785 • 15 weeks
|
|
Infections and infestations
Herpes zoster
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Infection
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Influenza
|
2.3%
18/785 • 15 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
46/785 • 15 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Pneumonia
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Sinusitis
|
2.7%
21/785 • 15 weeks
|
|
Infections and infestations
Tooth infection
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.25%
2/785 • 15 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.0%
47/785 • 15 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.25%
2/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.25%
2/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.25%
2/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.38%
3/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
3/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.38%
3/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.38%
3/785 • 15 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.38%
3/785 • 15 weeks
|
|
Investigations
Blood cholesterol increased
|
0.51%
4/785 • 15 weeks
|
|
Investigations
Blood glucose increased
|
0.25%
2/785 • 15 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.25%
2/785 • 15 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
2/785 • 15 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.38%
3/785 • 15 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
2/785 • 15 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.25%
2/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
9/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
4/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
17/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.51%
4/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.38%
3/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.76%
6/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.38%
3/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.38%
3/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.25%
2/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.89%
7/785 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.25%
2/785 • 15 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Balance disorder
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Dizziness
|
1.9%
15/785 • 15 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Headache
|
2.5%
20/785 • 15 weeks
|
|
Nervous system disorders
Migraine
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Sciatica
|
0.25%
2/785 • 15 weeks
|
|
Nervous system disorders
Somnolence
|
1.8%
14/785 • 15 weeks
|
|
Psychiatric disorders
Anxiety
|
0.38%
3/785 • 15 weeks
|
|
Psychiatric disorders
Depression
|
0.51%
4/785 • 15 weeks
|
|
Psychiatric disorders
Insomnia
|
0.38%
3/785 • 15 weeks
|
|
Renal and urinary disorders
Dysuria
|
1.5%
12/785 • 15 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.38%
3/785 • 15 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.64%
5/785 • 15 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
0.51%
4/785 • 15 weeks
|
|
Renal and urinary disorders
Urge incontinence
|
3.1%
24/785 • 15 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.38%
3/785 • 15 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.89%
7/785 • 15 weeks
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.64%
5/785 • 15 weeks
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.25%
2/785 • 15 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.25%
2/785 • 15 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.25%
2/785 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
15/785 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.25%
2/785 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.25%
2/785 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.51%
4/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.25%
2/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.25%
2/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.25%
2/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.64%
5/785 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.64%
5/785 • 15 weeks
|
|
Vascular disorders
Hot flush
|
0.25%
2/785 • 15 weeks
|
|
Vascular disorders
Hypertension
|
1.0%
8/785 • 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60