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.

NCT04534491 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18165
• Study Type: interventional
• Target: 855
• Locations: 1 country
• Sites: 1

Brief Summary

With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Approximately 15 weeks from subjects' initial purchase of Oxytrol

Secondary Outcomes (5)

• 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.

  Approximately 15 weeks from subjects' initial purchase of 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.

  Approximately 15 weeks from subjects' initial purchase of Oxytrol

• The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.

  Approximately 15 weeks from subjects' initial purchase of 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.

  Approximately 15 weeks from subjects' initial purchase of Oxytrol

• The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).

  Approximately 15 weeks from subjects' initial purchase of Oxytrol

Study Arms (1)

Oxytrol

EXPERIMENTAL

Subjects decided to purchase Oxytrol.

Drug: Oxybutynin (Oxytrol, BAY839380)

Interventions

Oxybutynin (Oxytrol, BAY839380) DRUG

Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)

Oxytrol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age or older
• Not pregnant or suspected to be pregnant
• Never trained or employed as a healthcare professional
• Neither the subject nor anyone in their household worked for a pharmaceutical company, a pharmacy, a managed care or health insurance company, a healthcare practice, or as a healthcare professional
• Had not participated in any market research study, product label study or clinical trial in the past 12 months

You may not qualify if:

• Symptoms of blood in the urine not related to menses
• Back pain and fever in conjunction with frequency or urgency and any of the following: dysuria, hematuria, or cloudy urine
• Narrow-angle glaucoma
• Pregnant (as determined by a urine pregnancy test among women of child bearing potential)
• Breastfeeding
• Known allergy to oxybutynin

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Stevenson Family Pharmacy

Saint Joseph, Missouri, 64504, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+)1-888-84 22937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: May 25, 2010
• Primary Completion: June 22, 2011
• Study Completion: June 22, 2011
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Locations

US (1)