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

October 6, 2014 updated by: Boehringer Ingelheim

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 to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: KUC 7483 CL
Drug: KUC 7483 CL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in "volume at first contraction"
Time Frame: 2 hours post dosing
2 hours post dosing
Change from baseline in "volume at first contraction"
Time Frame: 6 hours post dosing
6 hours post dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to 26 days
up to 26 days
Change from baseline in Detrusor pressure at first contraction
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in Maximum amplitude of involuntary detrusor contraction
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in Volume at first incontinence episode
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in compliance
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in Maximum cystometric capacity
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in Detrusor pressure at maximum flow induced by triggering
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
Change from baseline in Post-triggering residual urinary volume
Time Frame: 2 and 6 hours post dosing
2 and 6 hours post dosing
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
up to 24 hours post dosing
Cmax (maximum concentration of KUC 7322 ZW in plasma)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
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
up to 24 hours post dosing
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
up to 24 hours post dosing
tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
λz (terminal rate constant of KUC 7322 ZW in plasma)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
t1/2 (terminal half-life of KUC 7322 ZW in plasma)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
MRTpo (mean residence time of KUC 7322 ZW in the body after po administration)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
CL/F (apparent clearance of KUC 7322 ZW in the plasma after extravascular administration)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
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
up to 24 hours post dosing
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing
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
up to 24 hours post dosing
Number of patients with clinically significant changes in vital signs
Time Frame: up to 24 hours post dosing
Blood Pressure
up to 24 hours post dosing
Assessment of tolerability by investigator on a 4-point scale
Time Frame: 10 days post dosing
10 days post dosing
Assessment of tolerability by patient on a 4-point scale
Time Frame: 10 days post dosing
10 days post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1207.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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