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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Spinal Cord Injuries

Treatments

Drug: KUC 7483 CL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02259751

1207.4

Details and patient eligibility

About

Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483

Enrollment

26 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

A total daily volume of urine > 3000 ml as verified in the micturition diary before randomization
Treatment with drugs with known anticholinergic effect on the detrusor and/or alpha-blockers, 7 days prior to inclusion visit 2
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
Use of indwelling catheter
Any electro stimulation therapy within the 14 days prior to inclusion visit 2
Significant hepatic or renal disease defined as twice the upper limit of the reference range, regarding serum concentrations of Aspartate transaminase ((SGOT) (AST)), Alanine transaminase ((SGPT) ALT)), Alkaline phosphatase (ALP), and/or creatinine > 1.4 mg/dl
Diseases or any condition, in which treatment with ß3-adrenoceptors agonists is contraindicated
Participation in another clinical trail 8 weeks preceding to enrolment in this study or during study period
Patients with any severe medical or any other condition which in the opinion of the investigator makes the patient unsuitable for inclusion
Allergic to KUC-7483 or its excipients
Patients with Diabetes mellitus type 1 or 2 treated with oral antidiabetic drugs or insulin (any formulation)