Condition category
Urological and Genital Diseases
Date applied
15/02/2007
Date assigned
20/04/2007
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sheryl Caswell

ORCID ID

Contact details

Plethora Solutions
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
+44 (0)207 269 8630
sheryl.caswell@plethorasolutions.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSD506-OAB-002

Study information

Scientific title

Acronym

Study hypothesis

PSD506 is a novel selective muscarinic receptor antagonist that is being developed for the treatment of neurogenic detrusor overactivity in patients with spinal cord injury. Volume provocation tests in patients with spinal cord injury have previously been reported to be useful in assessing new putative treatments for neurogenic detrusor overactivity in spinal cord injury. This study aims to establish the volume provocation test as a surrogate endpoint for demonstrating the efficacy of PSD506 on urinary bladder contractions. This study will also assess the safety of PSD506 in subjects with neurogenic detrusor overactivity due to a spinal cord injury, and will investigate the effect on detrusor instability and function in this patient group.

Ethics approval

Wandsworth Research Ethics Committee on 17/10/06 (ref: 06/Q0803/161)

Study design

This is an open-label, single-centre, escalating dose, proof of concept study of the effects of single doses of PSD506 on volume provocation tests in subjects with stable spinal injuries above T12.

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Subjects with a diagnosis of detrusor hyper-reflexia secondary to spinal injury (mid-thoracic or cervical level)

Intervention

Single oral administration of PSD506 capsules 5 mg to 40 mg

Intervention type

Drug

Phase

Not Specified

Drug names

PSD506

Primary outcome measures

To determine the effects of single oral doses of PSD506 (anti-muscarinic antagonist) on the reduction of unstable urinary bladder detrusor contractions induced by volume provocation testing in patients with hyper-reflexia secondary to spinal injury.

Secondary outcome measures

1. To assess the safety of PSD06 in this population
2. To determine the dose-response of different doses of PSD506 on the reduction of unstable urinary bladder detrusor contractions

Overall trial start date

01/09/2006

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female subjects, aged 18 years or over
2. Spinal lesion above T12, which has been stable for at least 6 months prior to screening.
3. Detrusor hyper- reflexia secondary to spinal injury (mid-thoracic or cervical level) present for at least 12 months
4. If female, must either be surgically sterile or post-menopausal for the past year confirmed by a negative hormone panel (luteinizing hormone [LH], follicle stimulating hormone [FSH], 17β estradiol), or if of child-bearing potential be on adequate non-hormonal contraception (not oral or injectable) i.e. double barrier method or intrauterine contraceptive device [IUCD]. If male must also use adequate contraception (hormonal methods permitted)
5. Anti-muscarinic-naïve or treated subjects completing the 5 day wash-out period.
6. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 to 18 subjects

Participant exclusion criteria

1. If female, has a positive urine pregnancy test
2. History of drug or alcohol abuse
3. Use of anti-muscarinic agents with a long-half life e.g. solifenacin.
4. Body Mass Index (BMI) greater than 28 or less than 16
5. Mean sitting BP greater than 150/85 or less than 100/60 mmHg
6. Mean HR greater than 90 bpm or less than 50 bpm
7. Clinically significant orthostatic hypotension present at screening
8. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
9. History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure
10. History of significant central nervous system disease, including: transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances
11. History of peripheral vascular or cerebrovascular disease
12. History of narrow angle glaucoma or increased ocular pressure
13. Clinically significant bladder pathology, including urinary tract infection within 6 weeks of Day 0
14. History of diabetes
15. Clinically significant GI disorder which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
16. History of clinically significant liver disease, e.g., hepatitis B
17. Prohibited medications taken within 2 weeks
18. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp)
19. Clinically significant abnormalities in laboratory test results at screening (including hepatic and renal, full blood count, biochemistry and urinalysis)
20. Participation in an investigational drug or device study within 30 days prior to study.
21. Known hypersensitivity to anticholinergic agents
22. Concomitant disease or condition which could interfere with, or for which the treatment of might interfere with, the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
23. Unwillingness or inability to comply with the study protocol for any other reason.
24. Any clinically significant abnormality on 12-lead ECG

Recruitment start date

01/09/2006

Recruitment end date

30/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Plethora Solutions
London
WC2B 5NH
United Kingdom

Sponsor information

Organisation

Plethora Solutions Ltd (UK)

Sponsor details

Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
+44 (0)207 269 8630
mail@plethorasolutions.co.uk

Sponsor type

Industry

Website

http://www.plethorasolutions.co.uk/index.php

Funders

Funder type

Industry

Funder name

Plethora Solutions Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes