Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259751
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: KUC 7483 CL Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Determine Pharmacodynamic Effects and Pharmacokinetics of a Single Oral Dose of 320 mg KUC 7483 CL in Patients With Spinal Cord Injury and Neurogenic Detrusor Overactivity
Study Start Date : February 2004
Actual Primary Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: KUC 7483 CL Drug: KUC 7483 CL
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in "volume at first contraction" [ Time Frame: 2 hours post dosing ]
  2. Change from baseline in "volume at first contraction" [ Time Frame: 6 hours post dosing ]

Secondary Outcome Measures :
  1. Change from baseline in Detrusor pressure at first contraction [ Time Frame: 2 and 6 hours post dosing ]
  2. Change from baseline in Maximum amplitude of involuntary detrusor contraction [ Time Frame: 2 and 6 hours post dosing ]
  3. Change from baseline in Volume at first incontinence episode [ Time Frame: 2 and 6 hours post dosing ]
  4. Change from baseline in compliance [ Time Frame: 2 and 6 hours post dosing ]
  5. Change from baseline in Maximum cystometric capacity [ Time Frame: 2 and 6 hours post dosing ]
  6. Change from baseline in Detrusor pressure at maximum flow induced by triggering [ Time Frame: 2 and 6 hours post dosing ]
  7. Change from baseline in Post-triggering residual urinary volume [ Time Frame: 2 and 6 hours post dosing ]
  8. AUC0-∞ (area under the concentration time curve of KUC 7322 ZW in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 24 hours post dosing ]
  9. Cmax (maximum concentration of KUC 7322 ZW in plasma) [ Time Frame: up to 24 hours post dosing ]
  10. AUC0-tz (area under the concentration-time curve of KUC 7322 ZW in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 24 hours post dosing ]
  11. AUC0-24 (Area under the concentration time curve of KUC 7322 ZW in plasma over the time interval 0 to 24 hours) [ Time Frame: up to 24 hours post dosing ]
  12. tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma) [ Time Frame: up to 24 hours post dosing ]
  13. λz (terminal rate constant of KUC 7322 ZW in plasma) [ Time Frame: up to 24 hours post dosing ]
  14. t1/2 (terminal half-life of KUC 7322 ZW in plasma) [ Time Frame: up to 24 hours post dosing ]
  15. MRTpo (mean residence time of KUC 7322 ZW in the body after po administration) [ Time Frame: up to 24 hours post dosing ]
  16. CL/F (apparent clearance of KUC 7322 ZW in the plasma after extravascular administration) [ Time Frame: up to 24 hours post dosing ]
  17. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 24 hours post dosing ]
  18. Aet1-t2 (amount of KUC 7322 ZW that is eliminated in urine from the time interval t1 to t2) [ Time Frame: up to 24 hours post dosing ]
  19. fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2) [ Time Frame: up to 24 hours post dosing ]
  20. CLR,t1-t2 (renal clearance of KUC 7322 ZW in plasma from the time point t1 until the time point t2) [ Time Frame: up to 24 hours post dosing ]
  21. Number of patients with adverse events [ Time Frame: up to 26 days ]
  22. Number of patients with clinically significant changes in vital signs [ Time Frame: up to 24 hours post dosing ]
    Blood Pressure

  23. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: 10 days post dosing ]
  24. Assessment of tolerability by patient on a 4-point scale [ Time Frame: 10 days post dosing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02259751     History of Changes
Other Study ID Numbers: 1207.4
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
p-Hydroxyamphetamine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics