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

NCT ID: NCT02259751

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29

Brief Summary

Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KUC 7483 CL

Group Type: EXPERIMENTAL

KUC 7483 CL

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

KUC 7483 CL

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male patients with acquired suprasacral spinal cord injury practicing intermittent catheterization under stable condition as determined by the investigator

2. Recovery from spinal shock in posttraumatic patients

3. Aged 18 - 70 years

4. BMI range ≥ 18.5 and < 29.9 kg/m2

5. 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

6. Written informed consent consistent with International committee on harmonization (ICH)/ Good Clinical Practice (GCP) and local legislation given prior to any study procedures

7. Ability and willingness to comply with study treatment regimen and to attend study

Exclusion Criteria

1. A total daily volume of urine > 3000 ml as verified in the micturition diary before randomization

2. Treatment with drugs with known anticholinergic effect on the detrusor and/or alpha-blockers, 7 days prior to inclusion visit 2

3. Treatment with botulinus toxin, capsaicin or resiniferatoxin in the last 6 months prior to the study

4. Unstable dosage of any drug or the expectation of initiation of such a treatment during the trial

5. 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)

6. Neurological diseases other than suprasacral spinal cord injury, affecting urinary bladder function

7. Significant stress incontinence as determined by the investigator

8. Non-functional bladder outlet obstruction as determined by the investigator

9. Dilatation of the upper urinary tract

10. Low compliance bladder (Compliance < 20 mL/cm H2O)

11. Detrusor hyporeflexia/areflexia and bradykinesia/tremor of the external urethral sphincter

12. Prostatic or bladder carcinoma

13. Acute urinary tract infection during the run-in period or during study period

14. History of interstitial cystitis

15. 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

16. Pelvic radiation therapy

17. Use of indwelling catheter

18. Any electro stimulation therapy within the 14 days prior to inclusion visit 2

19. 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

20. Diseases or any condition, in which treatment with ß3-adrenoceptors agonists is contraindicated

21. Participation in another clinical trail 8 weeks preceding to enrolment in this study or during study period

22. Patients with any severe medical or any other condition which in the opinion of the investigator makes the patient unsuitable for inclusion

23. Allergic to KUC-7483 or its excipients

24. Patients with Diabetes mellitus type 1 or 2 treated with oral antidiabetic drugs or insulin (any formulation)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1207.4

Identifier Type: -

Identifier Source: org_study_id