An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12
| ISRCTN | ISRCTN81647490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81647490 |
| Secondary identifying numbers | PSD506-OAB-002 |
- Submission date
- 15/02/2007
- Registration date
- 20/04/2007
- Last edited
- 02/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Sheryl Caswell
Scientific
Scientific
Plethora Solutions
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
| Phone | +44 (0)207 269 8630 |
|---|---|
| sheryl.caswell@plethorasolutions.co.uk |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12 |
| Study objectives | 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(s) | Wandsworth Research Ethics Committee, 17/10/06,ref: 06/Q0803/161 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | PSD506 |
| Primary outcome measure | 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 study start date | 01/09/2006 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 to 18 subjects |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Plethora Solutions
London
WC2B 5NH
United Kingdom
WC2B 5NH
United Kingdom
Sponsor information
Plethora Solutions Ltd (UK)
Industry
Industry
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
| Phone | +44 (0)207 269 8630 |
|---|---|
| mail@plethorasolutions.co.uk | |
| Website | http://www.plethorasolutions.co.uk/index.php |
"ROR" |
https://ror.org/02y9vw172 |
Funders
Funder type
Industry
Plethora Solutions Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.
