Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder (REMOTE)

Viatris

Status and phase: Terminated; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: Tolterodine ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302938

A6121195

Details and patient eligibility

About

To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design

Enrollment: 18 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and 21 years or older
• Overactive bladder symptoms (subject-reported) for at least 3 months
• Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study

Exclusion criteria

• Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
• History of cystitis, continence, urogenitalcancer or radiation
• Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Tolterodine ER

Experimental group

Treatment:

Drug: Tolterodine ER

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo