NCT03482037

Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury

Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury

Detailed description

Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be conducted in specialized centres in Europe to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.

Conditions

• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Rec 0/0438 1 mg or Rec 0/0438 2 mg	Each vial content will be administered via the catheter used for the self-catheterization
DRUG	placebo	Each vial content will be administered via the catheter used for the self-catheterization

Timeline

• Start date: 2018-06-07
• Primary completion: 2019-03-27
• Completion: 2019-03-27
• First posted: 2018-03-29
• Last updated: 2021-01-29

Locations

9 sites across 4 countries: Czechia, France, Poland, Portugal