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

NCT03482037 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-01-29

No results posted yet for this study

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

Conditions

  • Neurogenic Detrusor Overactivity

Interventions

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

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Francisco Cruz, M.D. · Hospital São João, Urologia, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2019-03-27
Completion
2019-03-27

Countries

  • Czechia
  • France
  • Poland
  • Portugal

Study Locations

More Related Trials

Entities

Drugs

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 NCT03482037 on ClinicalTrials.gov