Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00317070 |
Date of registration:
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20/04/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
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Scientific title:
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A Randomized Controlled Trial to Evaluate the Efficacy and Tolerability of Intravesical Cocktail and Comparison With Intravesical Dimethyl Sulfoxide (DMSO) for the Treatment of Painful Bladder Syndrome Including Interstitial Cystitis (PBS/IC) |
Date of first enrolment:
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April 2006 |
Target sample size:
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10 |
Recruitment status: |
Terminated |
URL:
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http://clinicaltrials.gov/show/NCT00317070 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jerzy Gajewski, MD, FRCSC |
Address:
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Telephone:
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Email:
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Affiliation:
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Capital District Health Authority, Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Participants should be of age eighteen years or older
2. Participant has painful bladder syndrome and a score of 8 or greater on the painful
bladder syndrome symptom index (O'Leary-Sant)
3. Participant should have frequency and urgency of micturition and bladder pain for at
least 6 months
4. Participant should have voids at least 8 times during a 24 hour period and at least
once during the night as documented in the voiding diary and questionnaire.
5. Urine culture should not show any evidence of urinary tract infection.
6. Participant should be able to understand, speak, and read English.
7. Participant should be willing to take part in the study, including signing this form
after carefully reading it.
8. Participant consents to use a medically acceptable method of birth control throughout
the entire study period and for four weeks after the study is completed. Medically
acceptable methods of contraception that may be used by the study participants and/or
their partners include abstinence, birth control pills or patches, diaphragm with
spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical
sterilization, vasectomy, or progestin implants or injections.
9. Failure of other treatments for PBS/IC like pentosan polysulfate (failure is defined
as a score of +1 [slightly improved] or less on a global assessment response [GRA] 23
question to previous therapy)
Exclusion Criteria:
1. Participants who have undergone cystoscopy within 4 weeks of screening visit
2. Participants had other treatment given into the bladder in the past 4 weeks
3. Participants have used a new drug in the past 4 weeks which could affect bladder
symptoms (some antidepressants, anticholinergics, antihistamines)
4. Past history of treatment with cyclophosphamide
5. A positive pregnancy test at the time of screening
6. Currently breast feeding
7. History of uterine, cervical, or vaginal cancer during the past 3 years
8. History of significant vaginitis
9. History of major surgery in the last 6 months
10. Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV)
11. History of immune deficiency diseases
12. History of bleeding disorders
13. History of serious social, mental, or medical conditions that would stop patient
from taking part in the study
14. History of alcohol or drug abuse within the last 5 years
15. Participants who have history of prostate cancer or are being treated for chronic
bacterial prostatitis
16. History of liver disease or significant medical problem which the investigator
considers a risk for patient to be a part of the study
17. History of any of the following: neurogenic bladder radiation to pelvic area,
inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder
or ureteric calculi, or active genital herpes within 3 months of screening
18. Known hypersensitivity to one of the agents used in the intravesical instillation
19. Use of any investigational drug or device in the last 6 months
20. Participants who are unwilling or unable to abide by the requirements of the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bladder Diseases
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Interstitial Cystitis
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Intervention(s)
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Drug: IC Cocktail
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Drug: dimethyl sulfoxide
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Primary Outcome(s)
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reduction of frequency of micturition
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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overall improvement of symptoms
[Time Frame: 16 weeks]
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reduction in pain
[Time Frame: 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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