Study to Determine Pharmacodynamic Effects and Pharmacokinetics of KUC 7483 CL in Patients With Spinal Cord Injury and Neurogenic Detrusor Overactivity

NCT02259751 | Completed Phase 1

• 1 other identifier: 1207.4
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Change from baseline in "volume at first contraction"

  2 hours post dosing

• Change from baseline in "volume at first contraction"

  6 hours post dosing

Secondary Outcomes (24)

• Change from baseline in Detrusor pressure at first contraction

  2 and 6 hours post dosing

• Change from baseline in Maximum amplitude of involuntary detrusor contraction

  2 and 6 hours post dosing

• Change from baseline in Volume at first incontinence episode

  2 and 6 hours post dosing

• Change from baseline in compliance

  2 and 6 hours post dosing

• Change from baseline in Maximum cystometric capacity

  2 and 6 hours post dosing

Study Arms (2)

KUC 7483 CL

EXPERIMENTAL

Drug: KUC 7483 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KUC 7483 CL DRUG

KUC 7483 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with acquired suprasacral spinal cord injury practicing intermittent catheterization under stable condition as determined by the investigator
• Recovery from spinal shock in posttraumatic patients
• Aged 18 - 70 years
• BMI range ≥ 18.5 and \< 29.9 kg/m2
• Documented neurogenic detrusor overactivity as shown by urodynamics within the last 12 months prior to study start and confirmation by the baseline urodynamics (day 2). Detrusor overactivity is defined as a non-volitional increase in detrusor pressure of \> 6 cm H2O. Detrusor sphincter dyssynergia may be facultative
• Written informed consent consistent with International committee on harmonization (ICH)/ Good Clinical Practice (GCP) and local legislation given prior to any study procedures
• Ability and willingness to comply with study treatment regimen and to attend study

You may not qualify if:

• A total daily volume of urine \> 3000 ml as verified in the micturition diary before randomization
• Treatment with botulinus toxin, capsaicin or resiniferatoxin in the last 6 months prior to the study
• Unstable dosage of any drug or the expectation of initiation of such a treatment during the trial
• Use of agonists or antagonists at beta-adrenoceptors (The following drugs may nevertheless be used since they do not act upon beta-3 adrenoceptors in therapeutic doses: atenolol, bisoprolol, carvedilol, metoprolol, propranolol, salbutamol and salmeterol)
• Neurological diseases other than suprasacral spinal cord injury, affecting urinary bladder function
• Significant stress incontinence as determined by the investigator
• Non-functional bladder outlet obstruction as determined by the investigator
• Dilatation of the upper urinary tract
• Low compliance bladder (Compliance \< 20 mL/cm H2O)
• Detrusor hyporeflexia/areflexia and bradykinesia/tremor of the external urethral sphincter
• Prostatic or bladder carcinoma
• Acute urinary tract infection during the run-in period or during study period
• History of interstitial cystitis
• Surgery of the prostate, the urinary bladder, the urethra, and thermotherapy, ultrasound or laser therapy of the prostate for 12 months prior to enrolment to the study
• Pelvic radiation therapy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: February 1, 2004
• Primary Completion: February 1, 2005
• Last Updated: October 9, 2014

Record last verified: 2014-10