MedTrace Logo

Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury

NCT03187795 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-12-17

No results posted yet for this study

Summary

The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).

Conditions

  • Spinal Cord Injuries
  • Urinary Bladder, Neurogenic

Interventions

DRUG

Oxybutynin Chloride IR

Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks

DRUG

Mirabegron

Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Todd A. Linsenmeyer, M.D. · Kessler Institute for Rehabilitation

  • Steven C. Kirshblum, M.D. · Kessler Institute for Rehabilitation

  • Trevor A. Dyson-Hudson, M.D. · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2021-09-30
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03187795 on ClinicalTrials.gov