Phase II, multicentre, randomised, double-blind, placebo-controlled, pilot study to determine the efficacy, safety, tolerability and pharmacokinetics of intravesical PSD597 in reducing the pain of the bladder biopsy procedure

ISRCTN ISRCTN77602717
DOI https://doi.org/10.1186/ISRCTN77602717
Secondary identifying numbers PSD-PP-002
Submission date
25/09/2006
Registration date
12/10/2006
Last edited
08/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Dr Aaron Berger
Scientific

3822 Summit Street
Kansas City, Missouri
64111
United States of America

Phone +1 816 421 6400 ext 2184
Email aaron.berger@unitedbiosource.com

Study information

Study designThis is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPSD597 Bladder Biopsy
Study objectivesCystoscopies 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(s)1. Ethical Review Committee, Inc. (USA), approval gained 17 August 2006.
2. The Queen’s University and Affiliated Teaching Hospitals, Health Sciences Human Research Ethics Board (REB) (Canada), review information pending
Health condition(s) or problem(s) studiedPersons scheduled to undergo a bladder biopsy
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)PSD597 (consists of 200 mg lidocaine as 5ml of 4% lidocaine)
Primary outcome measureTo assess the change in bladder pain between baseline and immediately after the first bladder biopsy achieved by PSD597 versus placebo.
Secondary outcome measures1. 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 study start date18/09/2006
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40, to ensure 30 patients complete the study.
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/09/2006
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Canada
  • United States of America

Study participating centre

3822 Summit Street
Kansas City, Missouri
64111
United States of America

Sponsor information

Plethora Solutions Ltd (UK)
Industry

c/o Sheryl Caswell
11-13 Macklin Street
Covent Garden
London
WC2B 5NH
United Kingdom

Website http://www.plethorasolutions.co.uk
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan