Contact information
Type
Scientific
Primary contact
Dr Aaron Berger
ORCID ID
Contact details
3822 Summit Street
Kansas City
Missouri
64111
United States of America
+1 816 421 6400 ext 2184
aaron.berger@unitedbiosource.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSD-PP-002
Study information
Scientific title
Acronym
PSD597 Bladder Biopsy
Study hypothesis
Cystoscopies are often performed in the physician office using local anaesthesia in the form of 2% lidocaine gel which is squeezed through the urethra prior to insertion of the cystoscope. This results in anaesthesia of the urethra allowing passage of the cystoscope to be generally well tolerated. However, additional procedures beyond a visual diagnosis may not be possible as the local anaesthetic effect is limited to the urethra. Patients who are able to tolerate it do have bladder biopsies performed without anaesthesia but this procedure, though bearable, is painful. If a technique was available that allowed the anaesthetic effect to be extended beyond the urethral mucosa to the bladder mucosa and sub-mucosal space, it would be possible to carry out many more procedures in the office with a resulting reduction in cost and an increase in convenience and comfort to the patient.
Ethics approval
1. Ethical Review Committee, Inc. (USA), approval gained 17 August 2006.
2. The Queens University and Affiliated Teaching Hospitals, Health Sciences Human Research Ethics Board (REB) (Canada), review information pending
Study design
This is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Persons scheduled to undergo a bladder biopsy
Intervention
This is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study to determine proof of efficacy, safety, tolerability and pharmacokinetics of intravesical PSD597 in reducing the pain of bladder biopsy in the conscious patient receiving no sedation or other analgesia or anaesthesia except urethral anaesthesia with 2% lidocaine gel.
1. A single dose of PSD597 or placebo will be instilled via urinary catheter and remain in the bladder for 15 minutes before being drained through the cystocope sheath. PSD597 consists of 200 mg lidocaine (as 5ml of 4% lidocaine) instilled into an empty bladder via a urinary catheter followed by 5 ml 8.4% sodium bicarbonate solution.
2. Placebo consists of 10 ml normal saline instilled as two 5 ml instillates via a urinary catheter.
Standard treatment if discontinued from study.
Intervention type
Drug
Phase
Phase II
Drug names
PSD597 (consists of 200 mg lidocaine as 5ml of 4% lidocaine)
Primary outcome measures
To assess the change in bladder pain between baseline and immediately after the first bladder biopsy achieved by PSD597 versus placebo.
Secondary outcome measures
1. To assess the change in bladder pain between baseline and different aspects of the procedure following treatment with PSD597 versus placebo.
2. To assess the safety and tolerability of PSD597 dosed intravesically prior to bladder biopsy.
3. To measure systemic exposure to lidocaine following intravesical PSD597 in patients undergoing bladder biopsy.
Overall trial start date
18/09/2006
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males or Female aged over 18 years
2. Women of child bearing potential or men with partners of child bearing potential willing to commit to the use of a reliable form of contraception during the course of the study (e.g. contraceptive pill or condoms)
3. Able to understand and complete the Visual Analogue Pain Score (VAPS) form
4. Provide written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40, to ensure 30 patients complete the study.
Participant exclusion criteria
1. Receipt of another investigational product within one month prior to screening
2. Known hypersensitivity to amide-type local anaesthetics
3. Requirement for amide local anaesthetics pre-operatively other than 2% lidocaine for urethral anaesthesia prior to insertion of the cystocope
4. Clinically relevant abnormality on Electrocardiogram (ECG), such as prolonged QTc
5. History of alcohol or drug abuse within the past two years for which treatment has not been received
6. Clinically significant abnormal blood biochemistry or haematology
7. History of psychiatric illness, from vulnerable groups, or have learning difficulties
8. Female subjects who are pregnant or lactating
9. Presence of bladder, urethral, or ureteral calculi
10. Have taken an analgesic prior to the procedure (within specified time limits)
11. Known liver disease, known renal disease or heart-failure
12. Clinical evidence of urethritis
13. Urinary infection that has not resolved by Day one
Recruitment start date
18/09/2006
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Canada, United States of America
Trial participating centre
3822 Summit Street
Kansas City, Missouri
64111
United States of America
Sponsor information
Organisation
Plethora Solutions Ltd (UK)
Sponsor details
c/o Sheryl Caswell
11-13 Macklin Street
Covent Garden
London
WC2B 5NH
United Kingdom
Sponsor type
Industry
Website
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