Spinal Cord InjuriesPhase 1NCT02259751
Study to Determine Pharmacodynamic Effects and Pharmacokinetics of KUC 7483 CL in Patients With Spinal Cord Injury and Neurogenic Detrusor Overactivity
A Phase 1 study testing KUC 7483 CL in people with Spinal Cord Injuries, run by Boehringer Ingelheim.
Trial summary
Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483 Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- KUC 7483 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Feb 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
About this study
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 to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
- Conditions
- Spinal Cord Injuries
- Being tested
- KUC 7483 CL, Placebo
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUC 7483 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KUC 7483 CL | Experimental | Not described Receives: Drug: KUC 7483 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in "volume at first contraction"
Measured: 2 hours post dosing
Change from baseline in "volume at first contraction"
Measured: 6 hours post dosing
Secondary outcomes (24)
Change from baseline in Detrusor pressure at first contraction
Measured: 2 and 6 hours post dosing
Change from baseline in Maximum amplitude of involuntary detrusor contraction
Measured: 2 and 6 hours post dosing
Change from baseline in Volume at first incontinence episode
Measured: 2 and 6 hours post dosing
Change from baseline in compliance
Measured: 2 and 6 hours post dosing
Change from baseline in Maximum cystometric capacity
Measured: 2 and 6 hours post dosing
Change from baseline in Detrusor pressure at maximum flow induced by triggering
Measured: 2 and 6 hours post dosing
Change from baseline in Post-triggering residual urinary volume
Measured: 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)
Measured: up to 24 hours post dosing
Cmax (maximum concentration of KUC 7322 ZW in plasma)
Measured: 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)
Measured: 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)
Measured: up to 24 hours post dosing
tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma)
Measured: up to 24 hours post dosing
λz (terminal rate constant of KUC 7322 ZW in plasma)
Measured: up to 24 hours post dosing
t1/2 (terminal half-life of KUC 7322 ZW in plasma)
Measured: up to 24 hours post dosing
MRTpo (mean residence time of KUC 7322 ZW in the body after po administration)
Measured: up to 24 hours post dosing
CL/F (apparent clearance of KUC 7322 ZW in the plasma after extravascular administration)
Measured: up to 24 hours post dosing
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: 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)
Measured: up to 24 hours post dosing
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Measured: 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)
Measured: up to 24 hours post dosing
Number of patients with adverse events
Measured: up to 26 days
Number of patients with clinically significant changes in vital signs
Blood Pressure
Measured: up to 24 hours post dosing
Assessment of tolerability by investigator on a 4-point scale
Measured: 10 days post dosing
Assessment of tolerability by patient on a 4-point scale
Measured: 10 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startFeb 2004
- Primary completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259751
- Sponsor's protocol ID
- 1207.4
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02259751
- Acronym / sponsor ID
- 1207.4
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Feb 2005 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KUC 7483 CL | Experimental | Drug: KUC 7483 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KUC 7483 CL | Drug | KUC 7483 CL |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in "volume at first contraction"
Time frame: 2 hours post dosing
Change from baseline in "volume at first contraction"
Time frame: 6 hours post dosing
24 secondary outcomes
Change from baseline in Detrusor pressure at first contraction
Time frame: 2 and 6 hours post dosing
Change from baseline in Maximum amplitude of involuntary detrusor contraction
Time frame: 2 and 6 hours post dosing
Change from baseline in Volume at first incontinence episode
Time frame: 2 and 6 hours post dosing
Change from baseline in compliance
Time frame: 2 and 6 hours post dosing
Change from baseline in Maximum cystometric capacity
Time frame: 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
Change from baseline in Post-triggering residual urinary volume
Time frame: 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
Cmax (maximum concentration of KUC 7322 ZW in plasma)
Time frame: 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
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
tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma)
Time frame: up to 24 hours post dosing
λz (terminal rate constant of KUC 7322 ZW in plasma)
Time frame: 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
MRTpo (mean residence time of KUC 7322 ZW in the body after po administration)
Time frame: 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
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: 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
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time frame: 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
Number of patients with adverse events
Time frame: up to 26 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 24 hours post dosing
Assessment of tolerability by investigator on a 4-point scale
Time frame: 10 days post dosing
Assessment of tolerability by patient on a 4-point scale
Time frame: 10 days post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KUC 7483 CL in people with Spinal Cord Injuries, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in "volume at first contraction" (time frame: 2 hours post dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.