Status:
COMPLETED
Study to Determine Pharmacodynamic Effects and Pharmacokinetics of KUC 7483 CL in Patients With Spinal Cord Injury and Neurogenic Detrusor Overactivity
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Spinal Cord Injuries
Eligibility:
MALE
18-70 years
Phase:
PHASE1
Brief Summary
Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02259751
Start Date
February 1 2004
Last Update
October 9 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.